Wound retractor with gel cap

ABSTRACT

An incrementally adjustable wound retractor, which provides access to a body cavity, includes an inner ring having a diameter greater than the desired diameter of the wound incision, an outer ring having an annular axis and a diameter greater than the desired diameter of the wound incision, and a flexible sleeve disposed in a generally cylindrical form between the inner and outer rings. The outer ring includes first and second circular tubes spaced apart axially with each including a lumen having a rigid, noncompliant split hoop positioned therein. The outer ring may be rolled over itself and around the annular axis to retract the sleeve with sufficient force to stretch the incision to the desired diameter. A gel cap seal may be coupled to the outer ring outside of the biological body to seal the opening produced by the wound retractor between the body cavity and outside the body cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit of U.S. Provisional Patent ApplicationNo. 60/726,826, filed on Oct. 14, 2005; U.S. Provisional PatentApplication No. 60/745,730, filed on Apr. 26, 2006; U.S. ProvisionalPatent Application No. 60/803,346, filed on May 26, 2006; U.S.Provisional Patent Application No. 60/803,965, filed on Jun. 5, 2006;and, U.S. Provisional Patent Application No. 60/828,089, filed on Oct.4, 2006, the disclosures of which are hereby incorporated by referenceas if set forth in full herein.

BACKGROUND

This invention relates substantially to devices and other apparatusesfacilitating sealed access with surgical instruments, such as asurgeon's hand, across a body wall and into a body cavity. Thisinvention also relates to an improved wound retractor providing ease ofincremental retraction and alignment to fit a wide range of incisionsizes.

In several areas of surgery there exists a need to have mechanisms ordevices that can seal a body cavity or space, and yet permit theintroduction of surgical instruments such as guidewires, endoscopes, andeven the hand of a surgeon. Typical of these areas of surgery islaparoscopic surgery that relies on surgical instruments insertedthrough the abdominal wall to reach an operative site within theabdominal cavity. In order to increase space around the operative sitewithin the cavity, insufflation gases are typically introduced toinflate the cavity and elevate the abdominal wall. The pressurizing ofthe abdominal cavity is referred to as pneumoperitoneum. In thiscontext, the need to seal the body cavity or space arises from the needto maintain the pneumoperitoneum even when instruments are present.

Trocars have been commonly used to provide instrument access inlaparoscopic surgeries. These trocars have included elaborate sealstructures having zero seals that prevent the escape of the gases in theabsence of instruments, and instrument seals that prevent the escape ofthe gases in the presence of instruments. Unfortunately, the instrumentseals have been able to accommodate only a narrow range of instrumentdiameters. Multiple seal pairs had to be provided where wider rangeswere desired.

Some instruments, such as the hand of the surgeon, have been too largefor trocar access. Under these circumstances, hand-assisted laparoscopicseals have been provided. Such devices have been large, cumbersome, andlargely ineffective in providing the required sealing mechanism. Otheraccess devices, such as Touhy-Borst seals, have been used, but only forvery small diameter access such as that required by a guidewire.

Each of the prior devices suffers from drawbacks that make the devicedifficult or cumbersome to use. For example, a Touhy-Borst seal requirestwo hands to use and does not form a seal when a guidewire or otherdevice is about to be introduced. Present trocar seals and hand-assistedseals require two valves, one forming an instrument seal in the presenceof the instrument, and the other forming a zero seal in the absence ofthe instrument. For example, in hand-assisted devices, elaboratemechanisms have been required to seal around the surgeon's arm. When thearm is removed, a separate zero seal has been required to prevent theescape of blood or insufflation gases.

Surgery typically involves making an incision large enough toaccommodate a surgeon's hand and/or multiple instruments. The incisionmust be kept clean since it is susceptible to infection if touched bydiseased body parts and/or contaminated instruments. As such, woundprotectors are available to insure that exposed sides of an incision arecovered and protected from contaminants. A common deficiency of woundprotectors is their lack of ease of retraction adjustability andstability. There is a need in the art for an improved wound retractorthat can be easily retracted to fit a wide range of incision sizes.

SUMMARY

The invention is directed to a wound retractor that is adapted toretract a surgical incision in a biological body wall to a desireddiameter. The wound retractor includes a double-tube outer ring that hasan annular axis. The double-tube outer ring includes a first circulartube and a second circular tube that are separated axially. Each of thecircular tubes includes a lumen. The outer ring is adapted forjuxtaposition with an outer surface of the body wall and for dispositionrelative to the incision in the body wall. The wound retractor alsoincludes an inner ring that is adapted for juxtaposition with an innersurface of the body wall and for disposition relative to the incision inthe body wall. The wound retractor further includes a distensible sleevethat couples the outer ring to the inner ring. The sleeve is adapted totraverse the incision in the body wall. Additionally, the woundretractor includes a first substantially noncompliant, split hooppositioned in the lumen of the first circular tube and a secondsubstantially noncompliant, split hoop positioned in the lumen of thesecond circular tube. The outer ring is adapted to roll over itself andaround the annular axis to roll the sleeve around the outer ring.

In one aspect, each of the first and second split hoops functions as anaxle about which the outer ring may turn for half a rotation. In anotheraspect, the sleeve includes a material that is flexible and impermeableto fluids and bacteria. In another aspect, the inner ring is made ofmaterials having sufficient hardness to retain the shape of the innerring after insertion of the inner ring into a body cavity. In anotheraspect, the outer ring is made of materials that allow the outer ring tobe turned around its annular axis. In another aspect, the first circulartube of the outer ring is coupled to the second circular tube of theouter ring by a web. In another aspect, at least one of the first andsecond noncompliant split hoops includes a single split about itscircumference with the split creating a first end of the split hoop anda second end of the split hoop. In one aspect, the first and second endsof the split hoop substantially abut each other when the split hoop isin its neutral position. In another aspect, the split hoop includes aspace between the first and second ends when the split hoop is in itsneutral position. In this aspect, the space between the first and secondends of the split hoop is sufficient to substantially prevent the firstand second ends of the split hoop from contacting each other when thesplit hoop contracts while rolling the sleeve around the outer ring. Inanother aspect, at least one of the first and second noncompliant splithoops includes two or more splits about the circumference of the splithoop. The splits create a plurality of hoop portions with each hoopportion including a first end and a second end. The two or more splitsare substantially equally spaced about the circumference of the splithoop. In one aspect, the first and second ends of adjacent hoop portionssubstantially abut each other when the split hoop is in its neutralposition. In another aspect, the split hoop includes a space between thefirst and second ends of adjacent hoop portions when the split hoop isin its neutral position. In this aspect, the sum of the spaces betweenthe first and second ends of adjacent hoop portions is sufficient tosubstantially prevent the first and second ends of adjacent hoopportions from contacting each other when the split hoop contracts whilerolling the sleeve around the outer ring.

These and other features and advantages of the invention will becomemore apparent with a discussion of embodiments in reference to theassociated drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 a and 1 b illustrate an elevation view and a perspective view ofan incrementally adjustable wound retractor in accordance with anembodiment of the invention;

FIGS. 2 a through 2 c illustrate the retraction of the outer ring of thewound retractor of FIG. 1 to retract a desired incision;

FIG. 3 is a longitudinal cross-section view of the wound retractor ofFIG. 1 taken along line 3-3;

FIG. 4 illustrates the wound retractor of FIG. 1 deployed in anincision;

FIG. 5 is a cross-section view of a hollow tube of an outer ring of awound retractor;

FIG. 6 is a cross-section view of an inner rod of the outer ring of thewound retractor of FIG. 5;

FIG. 7 a is a side view of the incrementally adjustable wound retractorof FIG. 5;

FIG. 7 b is a cutaway side view of the incrementally adjustable woundretractor of FIG. 5;

FIG. 8 illustrates the retraction and alignment of the outer ring ofFIG. 7 to fit an incision;

FIG. 9 illustrates the wound retractor of FIG. 7 deployed in anincision;

FIG. 10 is a side section view of an outer ring of a wound retractorincluding a wire;

FIG. 11 is a side view of the outer ring of FIG. 10 being rolled toretract an incision;

FIG. 12 is a side view of the outer ring of FIG. 10 after being rolledto retract an incision;

FIG. 13 is a perspective section view of the wound retractor of FIG. 10;

FIG. 14 is a perspective section view of the hollow tube of the outerring of the wound retractor of FIG. 7;

FIG. 15 is a perspective section view of the inner rod of the outer ringof the wound retractor of FIG. 7;

FIG. 16 is a section view of the hollow tube and inner rod of FIG. 7coaxially joined;

FIGS. 17 a through 17 e are section views of the outer ring of theinvention;

FIGS. 18 a through 18 l are section views of hollow tubes and inner rodsof the outer rings;

FIGS. 19 a through 19 g are section views of outer rings havinggenerally prolate cross-sections;

FIGS. 20 a through 20 g are section views of outer rings havinggenerally prolate cross-sections and including lumens;

FIGS. 21 a through 21 e are section views of outer rings havinggenerally oblate cross-sections;

FIGS. 22 a through 22 e are section views of outer rings havinggenerally oblate cross-sections and including lumens;

FIG. 23 a is a section view of an outer ring having a triangularcross-section;

FIG. 23 b is a section view of the outer ring of FIG. 23 a furtherincluding a lumen;

FIG. 24 a is a section view of an outer ring having a cross-sectionincluding an odd number of sides, such as a pentagon;

FIG. 24 b is a section view of the outer ring of FIG. 24 a furtherincluding a lumen;

FIGS. 25 a through 25 b illustrate a process of forming the outer ring;

FIGS. 25 c through 25 e illustrate a process of forming the outer ring;

FIG. 26 is a section view of a surgical access device with a slightlymodified gel cap and/or abdominal base;

FIG. 27 is a section view of a surgical access device;

FIGS. 28-30 illustrate modifications that could be made to the gel capand/or the abdominal base so that the surgical access device can be usedwith the wound retractor;

FIG. 31 is a perspective view of a base of a surgical access device;

FIG. 32 is a section view of the embodiment illustrated in FIG. 31;

FIGS. 33 and 34 illustrate a base of a surgical access device having atleast one toggle or latch adapted to fit a corresponding cap ring;

FIGS. 35 and 36 illustrate a base of a surgical access device having araised wall on an inner diameter and adapted to fit a corresponding capring;

FIG. 37 is a perspective view of a wound retractor having a double-tubeouter ring with a rigid, noncompliant hoop positioned in each of thecircular tubes of the outer ring;

FIG. 38 is a plan view of the wound retractor of FIG. 37 disposed in awound in a biological body wall with the outer ring of the woundretractor not having the rigid, noncompliant hoops positioned in thecircular tubes of the outer ring;

FIG. 39 is a side section view of the double-tube outer ring of thewound retractor having a continuous hoop in one of the circular tubes ofthe outer ring and a split hoop in the other circular tube with the endsof the split hoop abutting each other;

FIG. 40 a is a section view taken from line 40 a-40 a in FIG. 39 andshowing the continuous hoop in a circular tube of the outer ring;

FIG. 40 b is a section view taken from line 40 b-40 b in FIG. 39 andshowing the split hoop in a circular tube of the outer ring;

FIGS. 41 a and 41 b depict the circular tube having the split hoop ofFIG. 39 being turned around the circular tube having the continuoushoop;

FIG. 42 is a side section view of the double-tube outer ring of thewound retractor having a continuous hoop in one of the circular tubes ofthe outer ring and the lumen of the other circular tube being hollow;

FIG. 43 is a section view taken from line 43-43 in FIG. 42 and showingthe continuous hoop in a circular tube of the outer ring;

FIG. 44 is a side section view of the double-tube outer ring of thewound retractor having a continuous hoop in one of the circular tubes ofthe outer ring and a split hoop in the other circular tube with a spacebetween the ends of the split hoop;

FIG. 45 a is a section view taken from line 45 a-45 a in FIG. 44 andshowing the continuous hoop in a circular tube of the outer ring;

FIG. 45 b is a section view taken from line 45 b-45 b in FIG. 44 andshowing the split hoop in a circular tube of the outer ring;

FIG. 46 is a side section view of the double-tube outer ring of thewound retractor having a continuous hoop in one of the circular tubes ofthe outer ring and a split hoop in the other circular tube with thesplit hoop having more than one split and the ends of the split hoopabutting each other;

FIG. 47 is a section view taken from line 47-47 in FIG. 46 and showingthe continuous hoop in a circular tube of the outer ring;

FIG. 48 is a section view taken from line 48-48 in FIG. 46 and showingthe split hoop in a circular tube of the outer ring;

FIG. 49 is a side section view of the double-tube outer ring of thewound retractor having a continuous hoop in one of the circular tubes ofthe outer ring and a split hoop in the other circular tube with thesplit hoop having more than one split and spaces between the ends of thesplit hoop;

FIG. 50 is a section view taken from line 50-50 in FIG. 49 and showingthe continuous hoop in a circular tube of the outer ring;

FIG. 51 is a section view taken from line 51-51 in FIG. 49 and showingthe split hoop in a circular tube of the outer ring;

FIG. 52 is a side section view of the double-tube outer ring of thewound retractor having a split hoop in each of the circular tubes of theouter ring with the split hoops each having a single split with the endsof each of the hoops abutting each other;

FIG. 53 is a section view taken from line 53-53 in FIG. 52 and showingthe split hoop in a circular tube of the outer ring;

FIG. 54 is a section view taken from line 54-54 in FIG. 52 and showingthe split hoop in a circular tube of the outer ring;

FIG. 55 is a side section view of the double-tube outer ring of thewound retractor having a split hoop in each of the circular tubes of theouter ring with the split hoops each having a single split with a spacebetween the ends of each of the hoops;

FIG. 56 is a section view taken from line 56-56 in FIG. 55 and showingthe split hoop in a circular tube of the outer ring;

FIG. 57 is a section view taken from line 57-57 in FIG. 55 and showingthe split hoop in a circular tube of the outer ring;

FIG. 58 is a side section view of the double-tube outer ring of thewound retractor having a split hoop in each of the circular tubes of theouter ring with the split hoops each having more than one split with theends of each of the hoop portions of each respective hoop abutting eachother;

FIG. 59 is a section view taken from line 59-59 in FIG. 58 and showingthe split hoop in a circular tube of the outer ring;

FIG. 60 is a section view taken from line 60-60 in FIG. 58 and showingthe split hoop in a circular tube of the outer ring;

FIG. 61 is a side section view of the double-tube outer ring of thewound retractor having a split hoop in each of the circular tubes of theouter ring with the split hoops each having more than one split with aspace between the ends of each of the hoop portions of each respectivehoop;

FIG. 62 is a section view taken from line 62-62 in FIG. 61 and showingthe split hoop in a circular tube of the outer ring;

FIG. 63 is a section view taken from line 63-63 in FIG. 61 and showingthe split hoop in a circular tube of the outer ring;

FIG. 64 is a side section view of a wound retractor having a triple-tubeouter ring with a continuous hoop positioned in the center circular tubeof the outer ring;

FIG. 65 is a section view taken from line 65-65 in FIG. 64 and showingthe continuous hoop in the lumen of the center circular tube of theouter ring;

FIGS. 66 a through 66 h are section views of various embodiments oftriple-tube outer rings for the wound retractor;

FIG. 67 is a section view of a wound retractor having an oval-shapedouter ring with a continuous hoop positioned within a lumen of the outerring;

FIG. 68 is a perspective view of a wound retractor having an inner ringat a distal end of the wound retractor and a pair of rigid, noncompliantsplit hoops toward the proximal end of the wound retractor;

FIG. 69 is a plan view of the wound retractor of FIG. 68 disposed in awound in a biological body wall with the wound retractor not having therigid, noncompliant hoops positioned toward the proximal end of thewound retractor;

FIG. 70 is a top perspective view of a gel cap having a lever forcoupling the gel cap to the outer ring of a wound retractor;

FIG. 71 is a bottom perspective view of a cap ring of the gel cap ofFIG. 70;

FIG. 72 is a bottom perspective view of the gel cap of FIG. 70

FIG. 73 is a partial section view of the gel cap of FIG. 70 coupled tothe outer ring of the wound retractor;

FIG. 74 is a top perspective view of the lever portion of the gel cap ofFIG. 70;

FIG. 75 is a partial bottom view of the cap ring of FIG. 70 with thelever in a first, open state;

FIG. 76 is a partial section view of the gel cap of FIG. 70 coupled tothe outer ring of the wound retractor with the lever in a second, closedstate;

FIG. 77 is a top perspective view of the gel cap of FIG. 70 coupled tothe wound retractor;

FIG. 78 is a partial bottom view of the cap ring of FIG. 70 with thelever in the second, closed state;

FIG. 79 is a partial section view of the gel cap of FIG. 70 coupled tothe outer ring of the wound retractor with the lever in a second, closedstate and the lever having a catch for engaging the outer ring of thewound retractor to hold the lever in the closed state;

FIG. 80 is a top plan view of a cap ring portion of a gel cap having aplurality of lips for coupling the gel cap to the outer ring of thewound retractor;

FIG. 81 is a bottom perspective view of the cap ring of FIG. 80depicting lips for engaging the outer ring of the wound retractor;

FIG. 82 is a top perspective view of the cap ring of FIG. 80;

FIG. 83 is a side section view of the cap ring of FIG. 80;

FIG. 84 is a side section view of the gel cap incorporating the cap ringof FIG. 80;

FIG. 85 is a bottom perspective view of the gel cap of FIG. 84;

FIG. 86 is a top perspective view of the gel cap of FIG. 84;

FIG. 87 is a top perspective view of the gel cap of FIG. 84 coupled tothe outer ring of the wound retractor;

FIG. 88 is a partial section view of the gel cap of FIG. 84 coupled tothe outer ring of the wound retractor;

FIG. 89 is a side view of the gel cap of FIG. 84 coupled to the outerring of the wound retractor;

FIG. 90 depicts a technique for placing a surgical wound retractorwithin an incision;

FIG. 91 depicts the surgical wound retractor within an incision;

FIG. 92 is a perspective view of an assembled surgical wound retractor;

FIG. 93 is a perspective view of an assembled surgical wound retractorof FIG. 92;

FIG. 94 is a perspective view of an assembled surgical wound retractorhaving a rigid central support in an outer ring of the wound retractor;

FIG. 95 is a plan view depicting a first step of a technique employed towind a sleeve of a wound retractor upon the rigid outer ring of thewound retractor;

FIG. 96 is a plan view depicting a second step of the technique employedto wind the sleeve of the wound retractor upon the rigid outer ring ofthe wound retractor;

FIG. 97 is a plan view depicting a third step of the technique employedto wind the sleeve of the wound retractor upon the rigid outer ring ofthe wound retractor;

FIG. 98 is a side view depicting the first step of the techniqueemployed to wind the sleeve of the wound retractor upon the rigid outerring of the wound retractor;

FIG. 99 is a side view depicting the second step of the techniqueemployed to wind the sleeve of the wound retractor upon the rigid outerring of the wound retractor;

FIG. 100 is a side view depicting the third step of the techniqueemployed to wind the sleeve of the wound retractor upon the rigid outerring of the wound retractor;

FIG. 101 is a side view of the assembled wound retractor prior towinding the sleeve upon the rigid outer ring;

FIGS. 102A through 102C are side views depicting the sequence of windingthe sleeve upon the rigid outer ring of the wound retractor;

FIGS. 103A through 103C are side views depicting the proportions ofchanges of the length of the sleeve as the winding of the sleeveprogresses;

FIG. 104 is a plan view of the rigid outer ring of the wound retractorin a normal at-rest state;

FIG. 105 is a plan view of the rigid outer ring of the wound retractorin an expanded state;

FIG. 106 is a plan view of the rigid outer ring of the wound retractorin a first winding state;

FIG. 107 is a plan view of the rigid outer ring of the wound retractorin a second winding state;

FIG. 108 is a plan view of the rigid outer ring in a normal at-reststate;

FIG. 109 is a plan view of the rigid outer ring in an expanded state;

FIG. 110 is a plan view depicting the positioning of a first rigid tubewithin the outer ring;

FIG. 111 is a plan view depicting the positioning of a second rigid tubewithin the outer ring;

FIG. 112 is a detail section view of the rigid outer ring;

FIG. 113 is a section view of a rigid outer ring having two portions;

FIG. 114 is a section view of a rigid outer ring having two portions;

FIG. 115 is a section view of a rigid outer ring having two portions;

FIG. 116 is a section view of a rigid outer ring having two portions;

FIG. 117 is a section view of the rigid outer ring having three portionswith a single lumen that is positioned in the center portion;

FIG. 118 is a section view of the rigid outer ring having three portionswith a lumen in each of the three portions;

FIG. 119 is a section view of the rigid outer ring having three portionswith a lumen in each of the three portions;

FIG. 120 is a section view of the rigid outer ring having three portionswith two lumens with the lumens being positioned in the outer portions;

FIG. 121 is a perspective view of an assembled wound retractor having atwisted, rigid outer ring;

FIG. 122 is a perspective view of the outer ring of the wound retractorof FIG. 121; and

FIG. 123 is a side view of the wound retractor of FIG. 121.

DETAILED DESCRIPTION

FIGS. 1 a, 1 b and 3 illustrate a wound retractor 100 in accordance witha first embodiment of the invention. The wound retractor 100 includes adouble-tube outer ring 102, an inner ring 104, and a distensible sleeve106 coupling the outer ring and the inner ring. The sleeve 106 may becoupled to the outer ring 102 and the inner ring 104 by heat seal,adhesive, or other means that are well known in the art. The sleeve 106may be made of a material that is flexible and impermeable to fluids andbacteria. The inner ring 104 may be made of materials of sufficienthardness to retain its shape after insertion into a body cavity 404(FIG. 4). The materials of which the outer ring 102 is made must allowthe outer ring to be turned around its annular axis as further describedbelow and illustrated in FIGS. 2 a-2 c. The shape of the outer ring 102affects both its ability to grip and to provide stability during andafter adjustment. The double-tube outer ring 102 includes a firstcircular tube 108 and a second circular tube 110 that are separatedaxially. The first and second circular tubes 108, 110 may be joinedtogether by a small web 112. Each of the circular tubes 108 and 110 maybe solid or include a lumen.

FIGS. 2 a-2 c illustrate the retraction and adjustment of the outer ring102 to fit an incision. In accordance with the invention, the woundretractor 100 is axially adjustable in increments. In particular, theupper end of the sleeve 106 can be wrapped around the outer ring 102 soas to tightly seal the sides or edges of the incision. The unique shapeof the outer ring 102 provides for an easy snap action when rolled aboutitself. The outer ring 102 also provides for incremental shortening ofthe sleeve 106 and for stability after installation. FIG. 3 illustratesa longitudinal cross-section view of the wound retractor 100 taken alongline 3-3.

FIG. 4 illustrates the wound retractor 100 deployed in a wound opening400. To deploy the wound retractor 100, an incision in the shape of aslit is first made in the body wall 402 of a patient, such as theabdominal wall 402. The inner ring 104 is compressed and the inner ringand sleeve 106 are manually inserted into the body cavity 404 throughthe incision with the outer ring 102 remaining external to the bodycavity. Once the inner ring 104 is within the body cavity 404, itexpands around the inner surface of the incision 400 so as to begenerally parallel to the outer surface of the abdominal wall 402. Thesleeve 106 provides a working channel from outside the body cavity 404to inside the body cavity.

The outer ring 102 initially rests above the abdominal wall 402 aroundthe wound opening 400. Since the upper end of the sleeve 106 is coupledto the outer ring 102, the sleeve 106 can be drawn upwards and radiallyoutward or inward, thereby drawing the inner ring 104 tightly againstthe inner surface of the abdominal wall 402. Moreover, the intermediateportion of the sleeve 106 is drawn tightly against the sides and edgesof the wound opening 400, thereby retracting the adjacent tissue andproducing a tightly sealed opening in the body cavity 404. The sleeve106 contacts the entire surface of the wound 400 and protectively coversand seals it from contamination and infection. Depending on the size anddepth of the incision 400, the user can roll up the sleeve 106 bygripping the double-tube outer ring 102 and turning it in a direction200 as illustrated in FIGS. 2 a-2 c until the sleeve 106 abuts the outeredge of the wound opening 400. The inner ring 104 is adapted forjuxtaposition with the inner surface of the abdominal wall 402 and theouter ring 102 is adapted for juxtaposition with the outer surface ofthe abdominal wall. Both the inner ring 104 and the outer ring 102 areadapted for disposition relative to the incision 400 in the abdominalwall 402. The sleeve 106 is adapted to traverse the incision 400 in theabdominal wall 402.

The outer ring 102 has a unique and novel double-tube configurationwherein through simple manipulation of forcing a first tube in a firstdirection and a second tube in a second direction, the positions of thefirst and second tubes can be inverted resulting in fast and easyturning of the tubes as illustrated in FIGS. 2 a-2 c. In one embodimentof the invention, the outer ring 102 is rotated by pushing the bottomtube or second circular tube 110 inward while pulling the top tube orfirst circular tube 108 outward (see FIG. 2 a). The combination of theabove steps results in inversion of the first and second circular tubesas illustrated in FIG. 2 c. The outer ring 102 can be rotated in 180°turns, thereby retracting the sleeve 106. The above process can berepeated until a desired compression or wound opening is achieved.

An advantage of the wound retractor 100 of the present invention is itprovides for an easier, faster and higher retraction rate than thatknown in the prior art, thereby resulting in less traumatic effects tothe patient. Another advantage of the wound retractor 100 of the presentinvention is it provides tactile gripping and incremental rolling of thesleeve 106 about the outer ring 102. In the above description, the firstand second tubes of the outer ring are in a vertical position but itshould be appreciated that the first and second tubes may be indifferent positions relative to one another, such as a horizontalposition. In comparison to retractors of the prior art, thesubstantially noncompliant hoops 118 in the lumens of the outer ring 102provide greater strength, which in turn provides better retraction. Thesubstantially noncompliant hoops 118 control the shape of the woundopening 400, rather than the wound opening controlling the shape of thewound retractor 100. In this manner, the wound retractor 100 of thepresent invention provides better isolation, protection, and sealing ofthe wound 400.

In another embodiment of the invention, a small wire 302, such as astainless steel wire, is placed inside a lumen of the double-tube outerring 102 (see FIGS. 3 and 10-13) so as to provide an audible signal asthe outer ring 102 is turned. As the double-tube outer ring 102 isturned, the wire 302 deflects against the tubing wall so as to provideaudible feedback to the user. Another feature of the wire 302 is itprovides retraction stability to the wound retractor 100.

After surgery, the wound retractor 100 may be retrieved by grabbing theinner ring 104 and the sleeve 106 and pulling them through the woundopening 400. The use of the sleeve 106 and the ease of retracting theouter ring 102 provide higher compression between the inner and outerrings. As a result, the wound retractor 100 provides incrementaladjustability to fit a wide range of incision sizes and isolates andprotects the wound from bacterial infection as diseased body parts andcontaminated instruments are passed through the wound.

FIGS. 5-9 and 14-16 illustrate a wound retractor 500 having a rollerdesign in accordance with another embodiment of the invention. The woundretractor 500 includes an outer ring 502, an inner ring 504, and adistensible sleeve 506 coupling the outer ring 502 and the inner ring504. The sleeve 506 can be coupled to the outer ring 502 and the innerring 504 by heat seal, adhesive or other means that are well known inthe art. The outer ring 502 also includes a hollow tube or lumen 508that has a fan-like shape cross-section as illustrated in FIG. 5. Theouter ring 502 further includes an inner rod 510 that has a similarfan-like geometry on its outer surface, as illustrated in FIG. 6. Thehollow tube 508 and the inner rod 510 are coaxially joined to form theouter ring 502 of the wound retractor 500.

The fan-like geometry of the outer ring 502 serves as an incrementalrotating mechanism. In particular, when the hollow tube 508 is manuallyrolled out of its coaxial alignment with respect to the inner rod 510,the hollow tube 508 will index itself until it matches the nextalignment point of the inner rod 510 as illustrated in FIG. 8. When thehollow tube 508 and the inner rod 510 are coaxially aligned, they lockin place, thereby preventing further indexing until the steps ofretracting are repeated. It is appreciated that each of the hollow tube508 and the inner rod 510 has at least one alignment point providingindexing and incremental rotation of the outer ring 502. That is, theouter ring 502 can incrementally retract in steps based on the number ofalignment points or indexes on the fan.

FIG. 9 illustrates a process of installing the wound retractor 500 in awound opening 900. An incision in the shape of a slit is first made in abody wall 902 of a patient, such as the abdominal wall. The inner ring504 is compressed and the inner ring and sleeve 506 are manuallyinserted into the body cavity 904 through the incision 900 with theouter ring 502 remaining external to the body cavity. Once the innerring 504 is within the body cavity 904, it expands around the innersurface of the incision 900 so as to be generally parallel to the outersurface of the abdominal wall 902. The sleeve 506 provides a workingchannel from outside the body cavity 904 to inside the body cavity.Retraction of the sleeve 506 can then be achieved by rolling the outerring 502 over the sleeve 506 in a direction 700 as shown in FIG. 8 untila desired compression or wound opening is achieved. Incrementalretraction is achieved by manually rolling the hollow tube 508 out ofits coaxial alignment with the inner rod 510, i.e., the hollow tube 508can be rolled and indexed to match the next alignment point between thehollow tube 508 and the inner rod 510.

The hollow tube 508 and the inner rod 510 lock in place when they arecoaxially aligned, thereby preventing further indexing until the outerring 502 is rolled out of its alignment again. This process is repeateduntil a desired retraction is achieved. Once surgery is complete, thewound retractor 500 can be retrieved by grabbing the inner ring 504 andthe sleeve 506 and pulling them through the wound opening 900.

It is appreciated that the outer ring can be designed in various shapesand sizes to achieve various retraction rates and/or to conform todifferent body surfaces as illustrated in FIGS. 17 a-17 e. For example,the outer ring may include a single tube or multiple tubes of differentshapes and sizes. The single or multiple tubes may be solid or includelumens of different shapes and sizes.

Similarly, the wound retractor having the roller design could be ofvarious geometries. As illustrated in FIGS. 18 a-18 l, hollow tubes 508a-508 l and inner rods 510 a-510 l, respectively, of the outer ring mayhave different shapes and sizes and may contain multiple lockingmechanisms. For example, the inner rods 510 b-510 e and 510 l have solidrectangular cross-sections. In comparison, the inner rods 510 f-510 khave hollow circular cross-sections. The hollow tubes and inner rods maybe made of the same or different materials (e.g., soft and/or hard). Forexample, the inner rods may be rigid, such as a wire or piece of metal,or they may be flexible, such as an extension spring. The lumens of thehollow tubes 508 a-508 l may have cross-sections of different geometriessuch as fan-like geometry, circular, oval, circular with lumps,triangular, rectangular, any geometric shape with multiple sides, etc.Advantages of the above embodiments of the invention include improvedretraction adjustability and stability.

FIGS. 19 a through 19 g illustrate additional embodiments of the outerring 190 of the invention having generally prolate cross-sections. Thelonger axis of the cross-section of the outer ring is generally parallelto an axis 92 of the outer ring as illustrated in FIG. 19 a. The outerring 190 can be turned around the axis 192 in either an outward orinward direction 800 to roll up the sleeve (not shown). The outer rings190 of FIGS. 19 a-19 g provide tactile gripping and incremental rollingof the sleeve about the rings. FIG. 19 b illustrates an outer ring 190having two straight chordal surfaces 190 a and 190 b that are generallyparallel to the axis 192. FIG. 19 c illustrates an outer ring having twostraight chordal surfaces and two curved chordal surfaces. FIGS. 19 d-19g illustrate outer rings having at least two curved chordal surfaces.

FIGS. 20 a through 20 g illustrate outer rings of FIGS. 19 a-19 g,respectively, including at least one lumen in each ring. The lumen mayhouse an inner rod (not shown) that deflects against the lumen wall,thereby providing audible feedback to the user. The lumen and inner rodmay be of different geometries and sizes.

FIGS. 21 a through 21 e illustrate additional embodiments of an outerring 194 of the invention having generally oblate cross-sections. Thelonger axis of the cross-section of the outer ring 194 is generallyperpendicular to an axis 196 as illustrated in FIG. 21 a. The outer ring194 can be turned around the axis 196 in either an outward or inwarddirection 900 to roll up the sleeve (not shown). The outer rings ofFIGS. 21 a-21 e provide tactile gripping and incremental rolling of thesleeve about the rings. FIGS. 21 b through 21 e illustrate outer ringshaving at least two curved chordal surfaces.

FIGS. 22 a-22 e illustrate the outer rings 194 of FIGS. 21 a-21 e,respectively, further including at least one lumen in each ring. Thelumen may house an inner rod (not shown) that deflects against the lumenwall, thereby providing audible feedback to the user. The lumen andinner rod may be of different geometries and sizes.

FIG. 23 a illustrates another embodiment of the outer ring of theinvention having a triangular cross-section, and FIG. 23 b illustratesthe outer ring of FIG. 23 a including a lumen. In another embodiment ofthe invention, FIG. 24 a illustrates the outer ring of the inventionhaving an odd number of sides, such as a pentagon, and FIG. 24 billustrates the outer ring of FIG. 24 a including a lumen. These outerrings provide tactile gripping and incremental rolling of the sleeveabout the rings. The lumens of the outer rings in FIGS. 23 b and 24 bmay be of different shapes and sizes to house inner rods (not shown)having different shapes and sizes. It is appreciated that the outer ringcan be designed in various shapes and sizes to achieve variousretraction rates and/or to conform to different body shapes.

FIGS. 25 a through 25 e illustrate different processes of forming theouter ring of the invention. The outer ring, which may be solid (FIG. 25b) or include a lumen (FIG. 25 e), may be molded as a circular ring asshown in FIGS. 25 a and 25 b, or the outer ring may be formed by joininga single or multiple extruded tubes into a circular ring as shown inFIGS. 25 c-25 e.

In another embodiment of the invention, access into and out of apatient's body is achieved by a hand assisted laparoscopic (HAL)procedure using a surgical access device such as the Gelport™ device asdescribed in applicants' international application PCT/US01/29682, filedon Sep. 21, 2001, entitled “Surgical Access Apparatus and Method,” whichis incorporated herein by reference, while retraction is provided by thewound retractor of the present invention. The purpose of this embodimentis to combine the features and advantages of both the wound retractor ofthe present invention and the surgical access device as described in thePCT application. As explained in the PCT application, the currentsurgical access device uses a polyisoprene sheath that is wrappeddistally around an O-ring, and once placed into a wound incision, thesheath is then stretched over extended tabs onto an abdominal base. Thesheath of the surgical access device requires stretching and often timesrequires multiple attempts to secure it to the abdominal base. A noveltyof this embodiment is to modify the cap and/or the abdominal base of thesurgical access device so that it will accept the wound retractor of thepresent invention to replace the polyisoprene sheath and to maintain anairtight seal. The use of the wound retractor would simplify the HALprocedure and would not require stretching.

Referring to FIG. 26, there is shown a surgical access device 1000 withslight or moderate modifications to a gel cap 1010 and to an abdominalbase 1020. The gel cap 1010 further includes a gel pad 1030 and acircumferential cap ring 1040, which can be inserted and molded to thepad 1030. The resulting gel cap 1010 forms a seal with the base 1020 anddefines a working channel through the pad 1030, the cap ring 1040, thebase 1020, and the sleeve 106 of the wound retractor. In this manner,the working channel includes a single valve formed by the gel pad 1030that provides both a zero seal and an instrument seal for a wide rangeof instrument diameters. Referring to FIG. 27, the gel cap 1010 aincludes an annular void 1042 a that is formed on the innercircumference of cap ring 1040 a. The void 1042 a is of particularadvantage in forming a sealing relationship with a base 1020 a. FIGS.28-30 illustrate additional exemplary embodiments of the inventionhaving modifications that could be made to the gel cap and/or theabdominal base so that the surgical access device can be used with thewound retractor.

FIG. 31 illustrates a perspective view of a base 1020 e in accordancewith another embodiment of the invention. FIG. 32 is a section view ofthe embodiment illustrated in FIG. 31. From these views, it will benoted that the base 1020 e can be provided with a smooth, generallycylindrical inner surface 1022 e which extends proximally to a roundedend surface 1024 e and outwardly from the end surface 1024 e along anannular lip 1026 e, which is sized and configured to fit into an annularvoid formed on the inner circumference of a corresponding cap ring.Proximal to the inner surface 1022 e, the base 1020 e can also include arounded end surface 1028 e along its inner diameter for securing theouter ring of the wound retractor once the sleeve has been shortened.

In another embodiment of the invention, FIGS. 33 and 34 illustrate abase 1020 f having a smooth generally cylindrical inner surface 1022 f,a rounded end surface 1024 f, an annular lip 1026 f, and an end surface1028 f having at least one toggle or latch 1029 f sized and configuredto fit a corresponding cap ring. In this embodiment, the toggle or latch1029 f operates to change the inner diameter of the cap ring to create aseal or release the cap ring from the base. In yet another embodiment ofthe invention, FIGS. 35 and 36 illustrate a base 1020 g having a smoothgenerally cylindrical inner surface 1022 g, a rounded end surface 1024g, an annular lip 1026 g, and an end surface 1028 g having a raised wallsized and configured to fit a corresponding cap ring.

Referring to FIGS. 37 and 38, other embodiments of a retractor 1100include a double-tube outer ring 1102 that is formed of a materialhaving a low durometer. The double-tube outer ring 1102 may be made ofan elastomeric material, such as a low durometer polymeric material. Theelastomeric material for forming the double-tube outer ring 1102 mayinclude Kraton. The low durometer material of the double-tube outer ring1102 does not have sufficient strength to adequately retract a wound1104 without the inclusion of a hoop placed within the outer ring. Asdepicted in FIG. 38, without a hoop within the outer ring 1102, a sleeve1106 of the retractor 1100 remains substantially closed when deployedthrough the wound 1104. Similar to previously described embodiments, thedouble-tube outer ring 1102 includes a first circular tube 1112 and asecond circular tube 1114. The first and second circular tubes 1112,1114 may each include a lumen.

Referring to FIGS. 39-40, the double-tube outer ring 1102 of the woundretractor 1100 may include a substantially rigid, noncompliant, firstcontinuous hoop 1116 in the first circular tube 1112 of the outer ring.The lumen of the second circular tube 1114 may include a substantiallynoncompliant, second split hoop 1118 therein. The split hoop 1118includes a hoop having a single split 1120 about its circumference withthe split creating a first end 1122 of the split hoop and a second end1124 of the split hoop. In its neutral position, the first and secondends 1122, 1124 substantially abut each other. As will be discussedbelow, the split 1120 in the hoop 1118 permits the circumference of thesplit hoop 1118 to expand and contract when rolling the sleeve 1106around the outer ring.

As shown in FIGS. 25 c through 25 e, the outer ring 1102 may be formedby transforming an extruded elastomeric tube into a circular ring. Toplace the continuous hoop 1116 into the first circular tube 1112, thehoop may include a split that produces at least a first and second end.One of the first and second ends of the hoop 1116 may be fed into thelumen of the first circular tube 1112 and continually fed untilsubstantially the entire hoop 1116 is within the lumen of the firstcircular tube. The at least first and second ends of the hoop 1116 maythen be joined together to form the continuous hoop 1116. The at leastfirst and second ends of the hoop 1116 may be joined by welding,brazing, mechanical means, or any other means that is well known in theart. The split hoop 1118 may be placed into the second circular tube1114 in similar fashion to placing the continuous hoop 1116 into thefirst circular tube 1112, except that the first and second ends 1122,1124 of the split hoop are not subsequently joined together.

Referring to FIGS. 41 a and 41 b, with the first circular tube 1112including the substantially rigid, noncompliant, continuous hoop 1116within its lumen, rolling the sleeve 1106 around the outer ring 1102includes turning the second circular tube 1114, which has the split hoop1118 within the lumen, about the first circular tube 1112. The first,continuous hoop 1116 functions as an axle about which the outer ring1102 is turned. The circumference of the second, split hoop 1118 expandswhen it is turned outside of the first circular tube 1112 and contractswhen it is turned inside of the first circular tube 1112. To facilitatecontraction of the circumference of the split hoop 1118, the lumen ofthe second circular tube 1114 is sufficiently larger than thecross-sectional periphery of the split hoop to permit the first andsecond ends 1122, 1124 of the split hoop to offset from each other andpermit a first end portion 1126 and a second end portion 1128 of thesplit hoop to overlap each other. Alternatively, the second circulartube 1114 may be formed of a material having sufficient elasticity tostretch and permit the first and second end portions 1126, 1128 tooverlap each other.

The substantially noncompliant hoops 1116, 1118 may be made of metals,such as stainless steel, piano wire heat treated to a spring temper, orother metals that produce a substantially noncompliant hoop. Thesubstantially noncompliant hoops 1116, 1118 may also be formed of rigidpolymeric materials through molding, machining, and other processes thatare well known in the art. The substantially noncompliant hoops 1116,1118 may also be formed of other suitable rigid materials that are wellknown in the art.

In comparison to retractors of the prior art, the substantiallynoncompliant hoop in a lumen of the outer ring provides greaterstrength, which in turn provides better retraction. The substantiallynoncompliant hoop controls the shape of the wound opening, rather thanthe wound opening controlling the shape of the retractor. In thismanner, the wound retractor of the present invention provides betterisolation, protection, and sealing of the wound.

In an embodiment similar to the embodiment depicted in FIGS. 39-40,FIGS. 42 and 43 depict a wound retractor 1130 having a substantiallyrigid, noncompliant, continuous hoop 1116 in the first circular tube1112 of the outer ring 1102 and the second circular tube 1114 having ahollow lumen. Having the lumen of the second circular tube 1114 hollowfacilitates easier turning of the second circular tube 1114 about thefirst circular tube 1112 when rolling the sleeve 1106 around the outerring 1102.

In another embodiment similar to the embodiment depicted in FIGS. 39-40,FIGS. 44-45 depict a wound retractor 1140 having a substantially rigid,noncompliant, first continuous hoop 116 in the first circular tube 1112of the outer ring 1102 and a second split hoop 1142 in the secondcircular tube 1114. However, the second split hoop 1142 in thisembodiment includes a space 1144 between the first end 1146 and thesecond end 1148 of the split hoop. The space 1144 between the first andsecond ends 1146, 1148 of the split hoop 1142 may be sufficient tosubstantially prevent the first and second ends from contacting eachother when the split hoop contracts while rolling the sleeve 1106 aroundthe outer ring 1102. In this manner, it is not necessary to providemeans for the first end portion 1150 and the second end portion 1152 ofthe second split hoop 1142 to overlap in the second circular tube 1114when the circumference of the split hoop contracts during rolling of thesleeve 1106 around the outer ring 1102.

In a further embodiment similar to the embodiment depicted in FIGS.39-40, FIGS. 46-48 depict a wound retractor 1160 having thesubstantially rigid, noncompliant, continuous first hoop 1116 in thelumen of the first circular tube 1112 and a substantially noncompliantsecond hoop 1162 having two or more splits 1164 about the circumferenceof the hoop 1162 in the lumen of the second circular tube 1114. Thesplits 1164 create first ends 1166 and second ends 1168 of each portionof the second split hoop 1162. The two or more splits 1164 may besubstantially equally spaced about the circumference of the second splithoop 1162. Adjacent first and second ends 1166, 1168 of the split hoop1162 substantially abut each other. Similar to the embodiment of FIGS.39-40, the circumference of the second split hoop 1162 expands when itis turned outside of the first circular tube 1112 and contracts when itis turned inside of the first circular tube with first end portions 1170of the split hoop and second end portions 1172 of the split hoopoverlapping each other during the contraction phase.

In an additional embodiment similar to the embodiment depicted in FIGS.39-40, FIGS. 49-51 depict a wound retractor 1180 having thesubstantially rigid, noncompliant, continuous first hoop 1116 in thelumen of the first circular tube 1112 and a substantially noncompliantsecond hoop 1182 having two or more splits 1184 about the circumferenceof the hoop 1182 in the lumen of the second circular tube 1114. Thesplits 1184 create first ends 1186, second ends 1188, first end portions1190 and second end portions 1192 of each portion of the second splithoop 1182. The first and second ends 1186, 1188 of adjacent hoopportions of the second split hoop 1182 are separated by spaces 1194 thatpermit the circumference of the split hoop 1182 to expand and contract.Similar to the embodiment of FIGS. 44 and 45, the circumference of thesecond split hoop 1182 expands when it is turned outside of the firstcircular tube 1112 and contracts when it is turned inside of the firstcircular tube. The sum of the spaces 1194 may be sufficient tosubstantially prevent the first and second ends 1186, 1188 of adjacenthoop portions from contacting each other when the second split hoop 1182contracts while rolling the sleeve 1106 around the outer ring 1102. Alsosimilar to the embodiment of FIGS. 44 and 45, it is not necessary toprovide means for the first end portions 1190 and the second endportions 1192 of the split hoop 1182 to overlap when the circumferenceof the split hoop contracts during rolling of the sleeve 1106 around theouter ring 1102.

Referring to FIGS. 52-54, a wound retractor 1200 may include thedouble-tube outer ring 1102 having a substantially noncompliant, firstsplit hoop 1118 positioned in the lumen of the first circular tube 1112and a substantially noncompliant, second split hoop 1118 positioned inthe lumen of the second circular tube 1114. As stated above, thesubstantially noncompliant, split hoop 1118 includes a single split 1120about its circumference with the split creating a first end 1122 of thesplit hoop, a second end 1124 of the split hoop, a first end portion1126 and a second end portion 1128 of the respective split hoop. Whenthe split hoop 1118 is in its neutral position, the first and secondends 1122, 1124 of the respective hoops 1118 substantially abut eachother.

With continued reference to FIGS. 52-54, with each of the first andsecond circular tubes 1112, 1114 including a split hoop 1118, it is notnecessary to provide means for the first end portion 1126 and the secondend portion 1128 to overlap each other when rolling the sleeve 1106around the outer ring 1102. Since the split hoop 1118 in the each of thefirst and second circular tubes 1112, 1114 has substantially abuttingfirst and second ends 1122, 1124 and no means are provided for the firstand second end portions 1126, 1128 of the split hoops to overlap eachother, each of the split hoops 1118 functions as an axle about which theouter ring 1102 may turn for half a rotation, or 180°. Moreparticularly, the first circular tube 1112 may be rolled outside thesecond circular tube 1114 with the circumference of the first split hoop1118 in the first circular tube expanding to clear the second split hoop1118 in the second circular tube. Then the second circular tube 1114 maybe rolled outside the first circular tube 1112 with the circumference ofthe second split hoop 1118 in the second circular tube expanding toclear the first split hoop 1118 in the first circular tube. These stepsmay be repeated until the wound 1104 is retracted to the desired degree.

In another embodiment similar to the embodiment depicted in FIGS. 52-54,FIGS. 55-57 depict a wound retractor 1210 having a double-tube outerring 1102 with a substantially noncompliant, first split hoop 1142positioned in the lumen of the first circular tube 1112 and asubstantially noncompliant, second split hoop 1142 positioned in thelumen of the second circular tube 1114. As stated above, thesubstantially noncompliant, split hoop 1142 includes a single splitabout its circumference with the split creating a first end 1146 of thesplit hoop, a second end 1148 of the split hoop, a first end portion1150 and a second end portion 1152 of the respective split hoop. Whenthe split hoop 1142 is in its neutral position, there is a space 1144between the first and second ends 1146, 1148 of the respective splithoop 1142. The spaces 1144 in each of the split hoops 1142 may besufficient to substantially prevent the first and second ends 1146, 1148from contacting each other when the split hoops contract while rollingthe sleeve 1106 around the outer ring 1102.

With continued reference to FIGS. 55-57, with each of the first andsecond circular tubes 1112, 1114 including a split hoop 1142, it is notnecessary to provide means for the first end portion 1150 and the secondend portion 1152 to overlap each other when rolling the sleeve 1106around the outer ring 1102. Since the split hoop 1142 in the each of thefirst and second circular tubes 1112, 1114 has a space 1144 between thefirst and second ends 1146, 1148, the split hoops 1142 may rotate abouteach other. More particularly, the first circular tube 1112 may berolled outside the second circular tube 1114 with the circumference ofthe first split hoop 1142 in the first circular tube expanding and thecircumference of the second split hoop 1142 in the second circular tubecontracting to clear each other. Then the second circular tube 1114 maybe rolled outside the first circular tube 1112 with the circumference ofthe second split hoop 1142 in the second circular tube expanding and thecircumference of the first split hoop 1142 in the first circular tubecontracting to clear each other. These steps may be repeated until thewound 1104 is retracted to the desired degree.

In another embodiment similar to the embodiment depicted in FIGS. 52-54,FIGS. 58-60 depict a wound retractor 1220 having a double-tube outerring 1102 with a substantially noncompliant, first split hoop 1162having two or more splits 1164 about the circumference of the split hooppositioned in the lumen of the first circular tube 1112 and asubstantially noncompliant, second split hoop 1162 having two or moresplits 1164 about the circumference of the split hoop positioned in thelumen of the second circular tube 1114. As stated above, the splits 1164create first ends 1166, second ends 1168, first end portions 1170 andsecond end portions 1172 of each portion of the respective split hoop1162. The two or more splits 1164 may be substantially equally spacedabout the circumference of the split hoops 1162. When the split hoops1162 are in their neutral positions, the first and second ends 1166,1168 of adjacent hoop portions of the respective split hoops 1162substantially abut each other.

With continued reference to FIGS. 58-60, with each of the first andsecond circular tubes 1112, 1114 including a split hoop 1162, it is notnecessary to provide means for the first end portions 1170 and thesecond end portions 1172 of adjacent portions of the split hoops tooverlap each other when rolling the sleeve 1106 around the outer ring1102. Since the portions of the split hoops 1162 in the each of thefirst and second circular tubes 1112, 1114 have substantially abuttingfirst and second ends 1166, 1168 and no means are provided for the firstand second end portions 1170, 1172 of the split hoops to overlap eachother, each of the split hoops 1162 functions as an axle about which theouter ring 1102 may turn for half a rotation. More particularly, thefirst circular tube 1112 may be rolled outside the second circular tube1114 with the circumference of the first split hoop 1162 in the firstcircular tube expanding to clear the second split hoop 1162 in thesecond circular tube. Then the second circular tube 1114 may be rolledoutside the first circular tube 1112 with the circumference of thesecond split hoop 1162 in the second circular tube expanding to clearthe first split hoop 1162 in the first circular tube. These steps may berepeated until the wound 1104 is retracted to the desired degree.

In another embodiment similar to the embodiment depicted in FIGS. 52-54,FIGS. 61-63 depict a wound retractor 1230 having a double-tube outerring 1102 with a substantially noncompliant, first split hoop 1182having two or more splits 1184 about the circumference of the split hooppositioned in the lumen of the first circular tube 1112 and asubstantially noncompliant, second split hoop 1182 having two or moresplits 1184 about the circumference of the split hoop positioned in thelumen of the second circular tube 1114. As stated above, the splits 1184create first ends 1186, second ends 1188, first end portions 1190 andsecond end portions 1192 of each portion of the respective split hoop1182. The two or more splits 1184 may be substantially equally spacedabout the circumference of the split hoops 1182. When the split hoops1182 are in their neutral positions, there is a space 1194 between thefirst and second ends 1186, 1188 of adjacent portions of the respectivesplit hoops 1182. The spaces 1194 permit the circumferences of therespective split hoops 1182 to expand and contract. The sum of thespaces 1194 of the respective split hoops 1182 may be sufficient tosubstantially prevent the first and second ends 1186, 1188 of adjacenthoop portions from contacting each other when the respective split hoops1182 contract while rolling the sleeve 1106 around the outer ring 1102.

With continued reference to FIGS. 61-63, with each of the first andsecond circular tubes 1112, 1114 including a split hoop 1182, it is notnecessary to provide means for the first end portions 1190 and thesecond end portions 1192 to overlap each other when rolling the sleeve1106 around the outer ring 1102. Since the split hoop 1182 in the eachof the first and second circular tubes 1112, 1114 has a space 1194between the first and second ends 1186, 1188 of adjacent portions of therespective split hoops 1182, the split hoops may rotate about eachother. More particularly, the first circular tube 1112 may be rolledoutside the second circular tube 1114 with the circumference of thefirst split hoop 1182 in the first circular tube expanding and thecircumference of the second split hoop 1182 in the second circular tubecontracting to clear each other. Then the second circular tube 1114 maybe rolled outside the first circular tube 1112 with the circumference ofthe second split hoop 1182 in the second circular tube expanding and thecircumference of the first split hoop 1182 in the first circular tubecontracting to clear each other. These steps may be repeated until thewound 1104 is retracted to the desired degree.

In other embodiments that incorporate the low-durometer, double-tubeouter ring 1102, combinations of the various split hoops 1118, 1142,1162, 1182 may be positioned within the first and second circular tubes1112, 1114 of the outer ring 1102. For example, one of the first andsecond circular tubes 1112, 1114 may include a split hoop 1118 having asingle split 1120 with the first and second ends 1122, 1124 of the splithoop substantially abutting each other. The other one of the first andsecond circular tubes 1112, 1114 may include either: a split hoop 1142having a single split with a space 1144 between the first and secondends 1146, 1148 of the split hoop 1142; a split hoop 1162 having two ormore splits 1164 with adjacent first and second ends 1166, 1168 ofadjacent hoop portions substantially abutting each other; or a splithoop 1182 having two or more splits 1188 with a space 1194 between thefirst and second ends 1186, 1188 of adjacent hoop portions. In anotherexample, one of the first and second circular tubes 1112, 1114 mayinclude a split hoop 1142 having a single split with a space 1144between the first and second ends 1146, 1148 of the split hoop 1142. Theother one of the first and second circular tubes 1112, 1114 may includeeither: a split hoop 1162 having two or more splits 1164 with adjacentfirst and second ends 1166, 1168 of adjacent hoop portions substantiallyabutting each other; or a split hoop 1182 having two or more splits 1188with a space 1194 between the first and second ends 1186, 1188 ofadjacent hoop portions. In another example, one of the first and secondcircular tubes 1112, 1114 may include a split hoop 1162 having two ormore splits 1164 with adjacent first and second ends 1166, 1168 ofadjacent hoop portions substantially abutting each other. The other oneof the first and second circular tubes 1112, 1114 may include a splithoop 1182 having two or more splits 1188 with a space 1194 between thefirst and second ends 1186, 1188 of adjacent hoop portions.

Referring to FIGS. 64 and 65, other embodiments of a wound retractor1300 include a triple-tube outer ring 1302, an inner ring 1304, and adistensible sleeve 1306 coupling the outer ring 1302 and the inner ring1304. The triple-tube outer ring 1302 includes a first circular tube1308, a second circular tube 1310 and a third circular tube 1312positioned between, and coupled to, the first and second circular tubes.The third circular tube 1312 includes a lumen. The first and secondcircular tubes 1308, 1310 may each include a lumen also. Thecross-sectional diameters of the first and second circular tubes 1308,1310 are substantially equal. The cross-sectional diameter of the thirdcircular tube 1312 may be smaller than the cross-sectional diameters ofthe first and second circular tubes 1308, 1310 or may be substantiallyequal to the cross-sectional diameters of the first and second circulartubes. The lumen of the third circular tube 1312 includes asubstantially rigid, noncompliant, continuous hoop 1314. The lumens ofthe first and second circular tubes 1308, 1310 may be hollow. In thismanner, the cross-section of the outer ring 1302 is substantiallysymmetrical.

Similar to the depiction in FIGS. 25 c through 25 e, the outer ring 1302may be formed by transforming an extruded elastomeric tube into acircular ring. To place the continuous hoop 1314 into the third circulartube 1312, the hoop may include a split that produces at least a firstand second end. One of the first and second ends of the hoop 1314 may befed into the lumen of the third circular tube 1312 and continually feduntil substantially the entire hoop 1314 is within the lumen of thethird circular tube. The at least first and second ends of the hoop 1314may then be joined together to form the continuous hoop 1314. The atleast first and second ends of the hoop 1314 may be joined by welding,brazing, mechanical means, or any other means that is well known in theart.

With the third circular tube 1312 including the substantially rigid,noncompliant, continuous hoop 1314 within its lumen, rolling the sleeve1306 around the outer ring 1302 includes turning the first and secondcircular tubes 1308, 1310 about the third circular tube 1312. Thecontinuous hoop 1314 functions as an axle about which the outer ring1302 is turned. Positioning the continuous hoop 1314 substantiallysymmetrically between the first and second circular tubes 1308, 1310provides even motion when turning the first and second circular tubesabout the continuous hoop 1314 to roll the sleeve 1306 around the outerring 1302.

In another aspect, depicted in FIGS. 66 a-66 d, the cross-sectionaldiameters of the first, second and third circular tubes 1308, 1310 and1312 may be substantially equal, or the cross-sectional diameter of thethird circular tube 1312 may be larger than the cross-sectionaldiameters of the first and second circular tubes 1308, 1310, as depictedin FIGS. 66 e-66 h. Also, the first and second circular tubes 1308, 1310may be solid, as depicted in FIGS. 66 a and 66 e. Alternatively, allthree circular tubes 1308, 1310, 1312 may include a lumen as depicted inFIGS. 66 b, 66 d and 66 f. With lumens in each of the three circulartubes 1308, 1310, 1312, the hoop 1314 may be included in only the thirdcircular tube 1312 (FIG. 66 f, in only the first and second circulartubes 1308 (FIG. 66 b), or in all three circular tubes 1308, 1310, 1312(FIG. 66 d). In another aspect, the third circular tube 1312 may besolid while the first and second circular tubes 1308, 1310 have lumenswith a hoop 1314 positioned in each of the lumens (FIG. 66 c). In afurther aspect, one of the first and second circular tubes 1308, 1310may be solid while the third circular tube 1312 and the other of thefirst and second circular tubes includes a lumen (FIGS. 66 g, 66 h) withthe hoop 1314 positioned in the lumen of the third circular tube. In anadditional aspect, the hoop 1314 may be inserted into the lumen of acircular tube 1308, 1310, 1312 via a slit 1316 in the wall of thecircular tube (FIG. 66 h).

Referring to FIG. 67, other embodiments of a wound retractor 1400include a single-tube outer ring 1402, an inner ring 1404, and adistensible sleeve 1406 coupling the outer ring 1402 and the inner ring1404. The single-tube outer ring 1402 includes a tube 1408 having asubstantially oval cross-section and a lumen 1410 positionedsubstantially in the center of the oval cross-section. A substantiallyrigid, noncompliant, continuous hoop 1412 is positioned within the lumen1410 of the tube 1408. In this manner, the cross-section of the outerring 1402 is substantially symmetrical.

Similar to the depiction in FIGS. 25 c through 25 e, the outer ring 1402may be formed by transforming an extruded elastomeric tube into acircular ring. To place the continuous hoop 1412 into the lumen 1410 ofthe tube 1408, the hoop may include a split that produces at least afirst and second end. One of the first and second ends of the hoop 1412may be fed into the lumen 1410 of the tube 1408 and continually feduntil substantially the entire hoop 1412 is within the lumen of thetube. The at least first and second ends of the hoop 1412 may then bejoined together to form the continuous hoop 1412. The at least first andsecond ends of the hoop 1412 may be joined by welding, brazing,mechanical means, or any other means that is well known in the art.

With the tube 1408 having the substantially rigid, noncompliant,continuous hoop 1412 within its lumen 1410, rolling the sleeve 1406around the outer ring 1402 includes turning the tube 1408 about the hoop1412. The continuous hoop 1412 functions as an axle about which the tube1408 is turned. Positioning the continuous hoop 1412 substantially inthe center of the tube 1408 provides even motion when turning the tube1408 about the continuous hoop 1412 to roll the sleeve 1406 around theouter ring 1402.

Referring to FIG. 68, other embodiments of a wound retractor 1500include a retraction sheath 1502 having a tubular wall 1504. The tubularwall 1504 has a configuration of the frustum of a cone 1506 at a distalportion 1508 of the sheath 1502 and a configuration of a cylinder 1510at a proximal portion 1512 of the sheath 1502. The distal end of theretraction sheath 1502 includes an inner ring 1514. The inner ring 1514may be flexible to facilitate insertion into a wound in a body wall of apatient. The retraction sheath 1502 may be made of an elastomericmaterial, such as a low durometer polymeric material. The elastomericmaterial for forming the retraction sheath 1502 may include neoprene.The low durometer material of the retraction sheath 1502 does not havesufficient strength to adequately retract a wound 1516 (FIG. 69) withoutthe inclusion of strengthening means, such as a hoop, placed within theproximal portion 1512 of the retraction sheath.

As depicted in FIG. 69, without strengthening means within the proximalportion 1512 of the retraction sheath 1502, the retraction sheathremains substantially closed even when deployed through the wound 1516.The proximal portion 1512 of the wound retractor 1500 may include a pairof substantially noncompliant, split hoops 1518 (FIG. 68) toward theproximal end 1520 of the retraction sheath 1502. The split hoops 1518each include a hoop having a single split 1522 about its circumferencewith the split creating a first end 1524 and a second end 1526 of thesplit hoop. In their neutral positions, the first and second ends 1524,1526 of the respective split hoops 1518 may substantially abut eachother.

Referring again to FIG. 68, one of the surfaces, such as the outersurface 1528, of the retraction sheath 1502 includes a first row 1530 ofa plurality of loops 1532 positioned about a circumference of theretraction sheath toward the proximal end 1520 of the retraction sheathand a second row 1534 of a plurality of loops 1532 positioned about acircumference of the retraction sheath toward the proximal end of theretraction sheath and distal to the first row 1530 of the plurality ofloops. The loops 1532 of each of the first and second rows 1530, 1534are sized and arranged to receive one of the split hoops 1518. A firstsplit hoop 1518 is fed through the loops 1532 in the first row 1530 ofloops and a second split hoop 1518 is fed through the loops 1532 in thesecond row 1534 of loops.

With continued reference to FIG. 68, with the first split hoop 1518positioned in the first row 1530 of loops 1532 and the second split hoop1518 positioned in the second row 1534 of loops 1532, the retractionsheath 1502 is retracted by rolling the split hoops 1518 outside of eachother with each of the split hoops 1518 performing as an axle aboutwhich the other split hoop is rolled outside of. More particularly, thefirst split hoop 1518 that is positioned in the first row 1530 of loops1532 may be rolled outside the second split hoop 1518 that is positionedin the second row 1534 of loops 1532 with the circumference of the firstsplit hoop 1518 that is positioned in the first row 1530 of loops 1532expanding to clear the second split hoop 1518 that is positioned in thesecond row 1534 of loops 1532. Then, the second split hoop 1518 that ispositioned in the second row 1534 of loops 1532 may be rolled outsidethe first split hoop 1518 that is positioned in the first row 1530 ofloops 1532 with the circumference of the second split hoop 1518 that ispositioned in the second row 1534 of loops 1532 expanding to clear thefirst split hoop 1518 that is positioned in the first row 1530 of loops1532. These steps may be repeated until the wound 1516 is retracted tothe desired degree.

Referring to FIG. 70, the surgical access device 1600, such as a gel cap1602, is used to seal the opening between the body cavity 404 (see FIG.4) and the area outside the body cavity while providing access into thebody cavity from outside the body cavity. The gel cap 1602 includes acap ring 1604 that couples to the outer ring 102 of the wound retractor100 and a gel pad 1606 coupled to the cap ring. The gel pad 1606 is madeof a gel material and includes an access portion 1608 or passage throughthe gel for providing passage from external the body to the body cavity404. In one aspect, the access portion 1608 may include a plurality ofintersecting dead-end slits 1660, 1662. The access portion 1608 forms aninstrument seal in the presence of an instrument, such as the arm of asurgeon, inserted therethrough and a zero seal in the absence of aninstrument inserted therethrough. Unlike foam rubber or other similartypes of elastic materials, the gel provides a gas tight seal around avariety of shapes and sizes of hands or instruments insertedtherethrough.

In one aspect, the gel material from which the gel pad 1606 is made isan elastomeric gel. Some such gels have been described in U.S. patentapplication Ser. No. 10/381,220, filed Mar. 20, 2003, the disclosure ofwhich is hereby incorporated by reference as if set forth in fullherein. The gel can be prepared by mixing a triblock copolymer with asolvent for the midblocks. The endblocks are typically thermoplasticmaterials, such as styrene, and the midblocks are thermoset elastomers,such as isoprene or butadiene, e.g., Styrene-Ethylene-Butylene-Styrene(SEBS). In one aspect, the solvent used is mineral oil. Upon heatingthis mixture or slurry, the midblocks are dissolved into the mineral oiland a network of the insoluble endblocks forms. The resulting networkhas enhanced elastomeric properties over the parent copolymer. In oneaspect, the triblock copolymer used is KRATON G1651, which has a styreneto rubber ratio of 33/67. Once formed, the gel is substantiallypermanent and by the nature of the endblocks is processable asthermoplastic elastomers henceforward. The mixture or slurry has aminimum temperature at which it becomes a gel, i.e., the minimum gellingtemperature (MGT). This temperature in one aspect corresponds to theglass transition temperature of the thermoplastic endblock plus a fewdegrees. For example, the MGT for the mixture of KRATON G1651 andmineral oil is about 120° C. When the slurry reaches the MGT and thetransformation to a gel state takes place, the gel becomes moretransparent, thereby providing a means for visually confirming when thetransformation of the slurry to the gel state is substantially completeand that the gel may be cooled. In addition to triblocks there are alsodiblock versions of the materials that may be used where Styrene ispresent at only one end of the formula, for example,Styrene-Ethylene/Butylene (SEB).

For a given mass of slurry to form into a complete gel, the entire massof the slurry is heated to the MGT and remains heated at the MGT forsufficient time for the end blocks to form a matrix of interconnections.The slurry will continue to form into gel at temperatures above the MGTuntil the slurry/gel reaches temperatures at which the components withinthe slurry/gel begin to decompose or oxidize. For example, when theslurry/gel is heated at temperatures above 250° C., the mineral oil inthe slurry/gel will begin to be volatile and oxidize. Oxidizing maycause the gel to turn brown and become oily.

The speed at which a given volume of slurry forms a gel is dependant onthe speed with which the entire mass of slurry reaches the MGT. Also,with the application of temperatures higher than the MGT, this speed isfurther enhanced as the end block networks distribute and form morerapidly.

The various base formulas may also be alloyed with one another toachieve a variety of intermediate properties. For example, KRATON G1701Xis a seventy percent (70%) SEB thirty percent (30%) SEBS mixture with anoverall Styrene to rubber ratio of 28/72. It can be appreciated that analmost infinite number of combinations, alloys, and Styrene to rubberratios can be formulated, each capable of providing advantages to aparticular embodiment of the invention. These advantages will typicallyinclude low durometer, high elongation, and good tear strength.

It is contemplated that the gel material may also include silicone, softurethanes and even harder plastics that might provide the desiredsealing qualities with the addition of a foaming agent. The siliconematerial may be of the types currently used for electronicencapsulation. The harder plastics may include polyvinyl chloride (PVC),isoprene, KRATON neat, and other KRATON/oil mixtures. In the KRATON/oilmixture, oils such as vegetable oils, petroleum oils and silicone oilsmay be substituted for the mineral oil.

Any of the gel materials contemplated could be modified to achievedifferent properties such as enhanced lubricity, appearance, and woundprotection. Additives may be incorporated directly into the gel orapplied as a surface treatment. Other compounds may be added to the gelto modify its physical properties or to assist in subsequentmodification of the surface by providing boding sites or a surfacecharge. Additionally, oil based colorants may be added to the slurry tocreate gels of different colors.

In one aspect, the mixture/slurry used with the various embodiments ofthe caps that are described herein are composed of ninety percent (90%)by weight of mineral oil and ten percent (10%) by weight of KRATONG1651. From a thermodynamic standpoint, this mixture behaves similar tomineral oil. Mineral oil has a considerable heat capacity and thereforeat about 130° C. it can take three (3) or four (4) hours to heat a poundof the slurry sufficiently to form a homogeneous gel. Once formed, thegel can be cooled as quickly as practical with no apparent deleteriouseffects on the gel. This cooling, in one aspect, is accomplished withcold-water immersion. In another aspect the gel may be air-cooled. Thosefamiliar with the art will recognize that other cooling techniques thatare well know in the art may be employed and are contemplated as withinthe scope of the present invention.

Many of the properties of the KRATON/oil mixture will vary withadjustments in the weight ratio of the components. In general, thegreater the percentage of mineral oil, the less firm the mixture; thegreater the percentage of KRATON, the more firm the mixture. If theresultant gel is too soft it can lead to excessive tenting or doming ofthe cap during surgery when a patient's abdominal cavity is insufflated.Excessive tenting or doming may cause the slits to open, providing aleak path. Additionally, if the gel is too soft it might not provide anadequate seal. However, the gel should be sufficiently soft to becomfortable for the surgeon while simultaneously providing good sealingboth in the presence of an instrument and in the absence of aninstrument.

If the slurry is permitted to sit for a prolonged period of time, thecopolymer, such as KRATON, and the solvent, such as mineral oil, mayseparate. The slurry may be mixed, such as with high shear blades, tomake the slurry more homogeneous. However, mixing the slurry mayintroduce or add air to the slurry. To remove air from the slurry, theslurry may be degassed. In one aspect, the slurry may be degassed in avacuum, such as within a vacuum chamber. In one aspect, the appliedvacuum may be 0.79 meters (29.9 inches) of mercury, or about one (1.0)atmosphere. The slurry may be stirred while under vacuum to facilitateremoval of the air. During degassing within a vacuum, the slurrytypically expands, then bubbles, and then reduces in volume. The vacuummay be discontinued when the bubbling substantially ceases. Degassingthe slurry in a vacuum chamber reduces the volume of the slurry by aboutten percent (10%). Degassing the slurry helps reduce the potential ofthe finished gel to oxidize.

Degassing the slurry tends to make the resultant gel firmer. A degassedslurry composed of about 91.6% by weight of mineral oil and 8.4% byweight of KRATON G1651, an eleven-to-one ratio, results in a gel havingabout the same firmness as a gel made from a slurry that is not degassedcomposed of ninety percent (90%) by weight of mineral oil and tenpercent (10%) by weight of KRATON G1651, a nine-to-one ratio.

Mineral oil is of a lighter density than KRATON and the two componentswill separate after mixing, with the lighter mineral oil rising to thetop of the container. This separation may occur when attempting to forma static slurry into gel over a period of several hours. The separationcan cause the resulting gel to have a higher concentration of mineraloil at the top and a lower concentration at the bottom, e.g., anon-homogeneous gel. The speed of separation is a function of the depthor head height of the slurry being heated. The mass of slurry combinedwith the head height, the temperature at which the gel sets and thespeed with which the energy can be transferred to the gel, factor intothe determination or result of homogeneous gel versus a non-homogeneousgel.

To combine the gel pad 1606 with the cap ring 1604, the cap ring may beplaced into a mold that includes the shape of the desired gel pad andthe uncured gel is added to the mold. Referring to FIG. 71, in oneaspect, the cap ring 1604 includes a substantially cylindrical ring 1610having a first, proximal portion 1612, a second, distal portion 1614 anda longitudinal axis 1616 (FIG. 70) extending through the proximal anddistal portions. The gel pad 1606 is positioned at the proximal portion1612 of the cap ring 1604. The proximal portion 1612 of the cap ring1604 may include a plurality of apertures 1618 distributed about thecircumference of the cap ring. The apertures 1618 may extend through thewall of the proximal portion 1612 of the cap ring 1604. Sufficient gelmay be added to the mold to cover and fill the apertures 1618 (see FIG.72). When adding uncured gel into the mold, the gel flows through theapertures 1618 and remains in the apertures. Also, for reasons that willbe described below, sufficient gel may be added to the mold to extendinto the distal portion 1614 of the cap ring 1604. When the gel pad 1606is cured, the gel in the apertures 1618 connects the gel at the outerportion 1620 of the cap ring 1604 to the gel at the inner portion 1622of the cap ring, thus forming a mechanical lock between the gel and thecap ring. As will be described in more detail below, other means may beused to couple the gel pad 1606 to the cap ring 1604.

The distal portion 1614 of the cap ring 1604 is substantiallycylindrical and is configured to receive the outer ring 102 of the woundretractor 100. In one aspect, the distal portion 1614 of the cap ring1604 includes a lip 1624 at the distal end 1626 thereof (see FIG. 71).The lip 1624 curves radially inwardly from the wall 1628 of the distalportion 1614 of the cap ring 1604 and extends around a portion of thecircumference of the cap ring. In one aspect, the lip 1624 extendsaround about 30° of the circumference of the cap ring 1604; however, thelip may extend longer or shorter distances around the circumference ofthe cap ring. The lip 1624 is configured to receive the distal-mostcircular tube 108, 110 of the outer ring 102 such that the outer ring ispositioned between the lip 1624 and the gel pad 1606 (see FIG. 73). Moreparticularly, when the outer ring 102 of the wound retractor 100 isreceived by the distal portion 1614 of the cap ring 1604, the outer ringof the wound retractor embeds into the gel pad 1606 at the distalportion of the cap ring and displaces the gel, thereby forming a sealbetween the gel pad and the outer ring and sleeve 106 of the woundretractor. This places the gel pad 1606 in juxtaposition with theincision 400.

In one aspect, the distal portion 1614 of the cap ring 1604 alsoincludes a swinging lever 1630 (FIG. 70) that swings on a plane that issubstantially perpendicular to the axis 1616 of the cap ring. In oneaspect, the lever 1630 is positioned substantially opposite the lip 1624on the distal portion 1614 of the cap ring 1604. The outer surface 1632of the cap ring 1604 may include a lug 1634 to which the lever 1630 iscoupled. In one aspect, the lug 1634 includes an aperture 1636 extendingsubstantially parallel to the longitudinal axis 1616 of the cap ring1604 and is adapted to receive a hinge pin 1638 portion of the lever1630. However, those familiar with the art will recognize that the hingepin may be positioned on the lug and the aperture may be positioned inthe lever. Also, other means that are well known in the art may be usedto hinge the lever to the cap ring. When coupled to the cap ring 1604,the lever 1630 includes a proximal end 1640 and a distal end 1642. Thelever 1630 includes a first, distal substantially flat lip 1644positioned at the distal end 1642 of the lever and lying in a plane thatis positioned substantially perpendicular to an axis 1646 of the pin1638 on the lever. It should be noted that the axis 1646 of the pin onthe lever 1630 is substantially parallel to the longitudinal axis 1616of the cap ring 1604. The lever 1630 may also include a second, proximalsubstantially flat lip 1648 positioned at the proximal end 1640 of thelever and also lying in a plane that is substantially perpendicular tothe axis 1646 of the pin 1638 on the lever such that the proximal lip ofthe lever is substantially parallel to the distal lip 1644 of the lever.Both of the distal and proximal lips 1644, 1648 of the lever 1630 extendfrom the same side of the lever.

In a first, open state (FIG. 75), the lever 1630 is swung outwardly,away from the body of the cap ring 1604 to provide clearance forinserting the outer ring 102 of the wound retractor 100 into the gelcap. In a second, closed state (FIG. 76), the lever 1630 is swung towardthe cap ring 1604 such that the distal and proximal lips 1644, 1648 ofthe lever protrude radially inwardly from the body of the lever andradially inwardly through the wall 1628 of the cap ring. In one aspect,the wall 1628 of the distal portion 1614 of the cap ring 1604 includesan aperture 1650 or groove for receiving the distal lip 1644 of thelever 1630. Similarly, the wall 1628 of the distal portion 1614 of thecap ring 1604 also includes a second aperture 1652, such as a slot, forreceiving and supporting the proximal lip 1648 of the lever 1630. In oneaspect, the distal lip 1644 on the lever 1630 extends around about 60°of the circumference of the cap ring and the proximal lip 1648 on thelever extends around about 45° of the circumference of the cap ring;however, the distal and proximal lips may extend longer or shorterdistances around the circumference of the cap ring.

In use, the wound retractor 100 is first used to retract the incision inthe body wall of a patient, as described above. With the lever 1630 inthe first state, the gel cap 1602 is brought to the outer ring 102 ofthe wound retractor 100 at an angle with the lip portion 1624 of the capring 1604 toward the patient. The lip portion 1624 of the cap ring isslid under the distal-most circular tube 108, 110 of the outer ring 102,between the outer ring and the patient, and then the remainder of thegel cap 1602 is swung onto the outer ring. The lever 1630 is then swungclosed into the second state (FIG. 77). In the second state, the distallip 1644 of the lever 1630 abuts the distal surface of the distal-mostcircular tube 108, 110 of the outer ring 102 of the wound retractor 100and secures the gel cap 1602 to the wound retractor. More particularly,with the gel cap 1602 mounted onto the outer ring 102 of the woundretractor 100 and the lever 1630 positioned in the second state, the lipportion 1624 of the cap ring 1604 and the distal lip 1644 of the leverreceive the outer ring of the wound retractor. The outer ring 102 of thewound retractor 100 is positioned between the lip portion 1624 of thecap ring 1604 and the distal lip 1644 of the lever 1630 at the distalend of the outer ring of the wound retractor and the gel pad 1606 at theproximal end of the outer ring of the wound retractor.

The lever 1630 includes locking means 1654 (FIG. 74) to preventunintended opening of the lever from the second state to the firststate. In one aspect, to positively lock the lever 1630 into the secondstate, one of the distal and proximal lips 1644, 1648 of the leverincludes a latch 1656 that engages the aperture/groove 1650, 1652 in thecap ring through which the lip protrudes (see FIG. 78). In anotheraspect, the distal lip 1644 of the lever 1630 includes a catch 1658(FIG. 79) protruding proximally to engage the distal-most circular tube108, 110 of the outer ring 102 of the wound retractor 100 at a positionon the inner circumference of the outer ring.

With the gel cap 1602 mounted onto the outer ring 102 of the woundretractor 100 and the lever 1630 positioned in the second state, theproximal lip 1648 on the lever positioned in the aperture 1652 in thecap ring 1604 provides support for the lever to counteract cantileverforces induced by the displaced gel of the gel pad 1606. Support of theproximal lip 1648 also helps the distal lip 1644 maintain the positionof the outer ring 102 of the wound retractor 100 against the gel pad1606.

In another aspect, the gel cap 1602 may include more than one lever 1630with the levers substantially equally spaced between each other and thelip 1624 on the cap ring 1604. In a further aspect, the lip 1624 on thecap ring 1604 may be omitted and at least two levers 1630 used to securethe gel cap 1602 to the wound retractor 100.

The gel cap 1602 with the lip 1624 and lever 1630 on the cap ring isbest suited for use with wound retractors 100 having an outer ring 102that is substantially rigid and noncompliant. If the outer ring 102 ofthe wound retractor 100 were not rigid, the outer ring would tend topull out of the gel cap 1602, thereby compromising the seal between thegel pad 1606 and the wound retractor and potentially resulting indeflation of the insufflated body cavity.

In one aspect, cyanoacrylate, e.g., SUPERGLUE or KRAZY GLUE, may be usedto bond or otherwise attach the gel pad 1606 to the cap ring 1604. Theglue may attach to either the rubber or styrene component of thetri-block and the bond is frequently stronger than the gel materialitself. In another aspect, a solvent may be used to dissolve theplastics in the cap ring 1604 and the polystyrene in the gel pad 1606.The solution of solvent is applied to the gel pad 1606 and cap ring 1604in either a spray or dip form. In effect, the solution melts both theplastic of the cap ring 1604 as well as the polystyrene in the gel pad1606 to allow a chemical bond to form between the two, which remainswhen the solvent evaporates.

In one aspect, gel is cast into a DYNAFLEX or KRATON polymer supportstructure, e.g., the cap ring 1604. By using KRATON polymer or a similarmaterial in the cap ring 1604, ring adhesion between the gel pad 1606and the cap ring can be achieved. The polystyrene in the gel pad 1606 isidentified as achieving adhesion with polyphenylene oxide (PPO),polystyrene and other polymers.

In the casting process the gel pad 1606 and the cap ring 1604 are heatedto a temperature above about 130° C. and held at that temperature forseveral hours, e.g., about three (3) to four (4) hours. The temperatureused is not sufficient to deform the cap ring 1604.

The cap ring 1604 in one aspect includes a polymer, e.g., polyethylene(PE). In one aspect, the polyethylene is a low density polyethylene(LDPE) or high density polyethylene (HDPE), or ultra high molecularweight polyethylene (UHMWPE). In one aspect, the cap ring 1604 may bemade of a polymer, such as polycarbonate and may be fabricated bymethods including injection molding.

The gel includes mineral oil. PE has a higher molecular weight thanmineral oil. PE is dissolved by mineral oil at high temperatures. Assuch, as the PE and the mineral oil in the gel pad intermix as both areheated to and held at temperatures above about 130° C., a bond betweenthe PE and gel pad is formed.

In one aspect, the cap ring 1604 includes polycarbonate. Thepolycarbonate of the cap ring 1604 does not form bonds with gel at 130°C. However, by raising the temperature to about 150° C. for a fewminutes during casting, bonding occurs between the gel pad 1606 and thecap ring 1604. As such, heating the gel pad 1606 and cap ring 1604 totemperatures at which both the polystyrene of the gel and thepolycarbonate are simultaneously beyond their melt points allows bondsto form between the gel pad 1606 and the cap ring 1604. Alternatively,the gel pad 1606 and cap ring 1604 may be heated to near or at the glasstransition temperature of the polycarbonate cap ring to form the bondbetween the gel pad and the cap ring.

Referring to FIGS. 80-89, another embodiment of a gel cap 1700 includesa cap ring 1702 that couples to the outer ring 102 of the woundretractor 100 and a gel pad 1704 coupled to the cap ring. Similar to theaspect of the gel cap 1602, the gel pad 1704 is made of a gel materialand includes an access portion 1706 or passage through the gel forproviding a passage from external the body to the body cavity 404. Inone aspect, the access portion 1706 may include a plurality ofintersecting dead-end slits 1728, 1730. The access portion 1706 forms aninstrument seal in the presence of an instrument, such as the arm of asurgeon, inserted therethrough and a zero seal in the absence of aninstrument inserted therethrough.

To combine the gel pad 1704 with the cap ring 1702, the cap ring may beplaced into a mold that includes the shape of the desired gel pad andthe uncured gel is added to the mold. In one aspect, the cap ring 1702includes a substantially cylindrical ring 1708 having a first, proximalportion 1710, a second, distal portion 1712 and a longitudinal axis 1714extending through the proximal and distal portions. The gel pad 1704 ispositioned at the proximal portion 1710 of the cap ring 1702. Theproximal portion 1710 of the cap ring 1702 may include a plurality ofapertures 1716 distributed about the circumference of the cap ring. Theapertures 1716 may extend through the wall of the proximal portion 1710of the cap ring 1702. Sufficient gel may be added to the mold to coverand fill the apertures 1716. When adding uncured gel into the mold, thegel flows through the apertures 1716 and remains in the apertures. Also,for reasons that will be described below, sufficient gel may be added tothe mold to extend into the distal portion 1712 of the cap ring 1702.When the gel pad 1704 is cured, the gel in the apertures 1716 connectsthe gel at the outer portion 1718 of the cap ring 1702 to the gel at theinner portion 1720 of the cap ring, thus forming a mechanical lockbetween the gel and the cap ring.

The distal portion 1712 of the cap ring 1702 is substantiallycylindrical and is configured to receive the outer ring 102 of the woundretractor 100. In one aspect, the distal portion 1712 of the cap ring1702 includes a plurality of lips 1722 at the distal end 1724 thereof.The lips 1722 curve radially inwardly from the wall 1726 of the distalportion 1712 of the cap ring 1702 and extend around a portion of thecircumference of the cap ring. In one aspect, there are three lips 1722equally spaced about the circumference of the distal portion 1712 of thecap ring 1702. Each of the three (3) lips may extend about 60° aroundthe circumference of the cap ring 1702; however, the lips may extendlonger or shorter distances around the circumference of the cap ring.Also, there may be more lips 1722 with each lip extending a shorterdistance around the circumference of the cap ring 1702 and the more thanthree lips being substantially equally spaced about the circumference ofthe distal portion of the cap ring. In another aspect, there may be twolips 1702 that are substantially diametrically opposed about thecircumference of the distal portion of the cap ring with each of thelips extending a sufficient distance around the circumference of the capring 1702 to facilitate adequate coupling of the gel cap 1700 to theouter ring 102 of the wound retractor 100. The lips 1722 are configuredto receive the distal-most circular tube 108, 110 of the outer ring 102of the wound retractor 100 such that the outer ring is positionedbetween the lips 1722 and the gel pad 1704. More particularly, when theouter ring 102 of the wound retractor 100 is received by the distalportion 1712 of the cap ring 1702, the outer ring of the wound retractorembeds into the gel pad 1704 at the distal portion 1712 of the cap ring1702 and displaces the gel, thereby forming a seal between the gel padand the outer ring and sleeve 106 of the wound retractor. This placesthe gel pad 1704 in juxtaposition with the incision 400.

In use, the wound retractor 100 is first used to retract the incision inthe body wall of a patient, as described above. The gel cap 1700 isbrought to the outer ring 102 of the wound retractor 100 at an angle,with one of the lip portions 1722 of the cap ring 1702 toward thepatient. The lip portion 1722 of the cap ring that is toward the patientis slid under the distal-most circular tube 108, 110 of the outer ring102, between the outer ring and the patient, and then the remainder ofthe gel cap 1700 is swung onto the outer ring with the remaining lipportions snapping into place under the distal-most circular tube. In analternative aspect, the gel cap 1700 may be brought to the outer ring102 substantially parallel to the outer ring and the lip portions 1722snapped into place under the distal-most circular tube 108, 110 of theouter ring 102 at the same time.

The gel cap 1700 with the plurality of lips 1722 on the cap ring 1702 isbest suited for use with wound retractors 100 having an outer ring 102that is substantially rigid and noncompliant. If the outer ring 102 ofthe wound retractor 100 were not rigid, the outer ring would tend topull out of the gel cap 1700, thereby compromising the seal between thegel pad 1704 and the wound retractor and potentially resulting indeflation of the insufflated body cavity.

The cap ring 1702 in one aspect includes a polymer, e.g., polyethylene(PE). In one aspect, the polyethylene is a low density polyethylene(LDPE) or high density polyethylene (HDPE), or ultra high molecularweight polyethylene (UHMWPE). In one aspect, the cap ring 1702 may bemade of a polymer, such as polycarbonate and may be fabricated bymethods including injection molding.

Referring to the drawings, FIGS. 90 and 91 depict the placement of awound retractor 1800 into an incision 1802 made through a body wall 1804of a patient 1806. Generally, a first, inner ring 1808 is deformed andplaced into the incision 1802. The first, inner ring 1808 is releasedwhen it has passed through the body wall 1804 of the patient 1806 andhas reached a body cavity 1810 or a reasonably open space. The innerring 1808 typically returns to a substantially circular condition and issubsequently drawn or pulled outwardly and against the inner surface1812 of the body wall 1804. Tension between the inner ring 1808 and theexternal components, such as a second, outer ring 1814, of the woundretractor 1800 is transmitted by means of a substantially cylindricaldistensible sleeve 1816 that is coupled between the inner ring 1808 andthe outer ring 1814. Tension is increased between the inner and outerrings 1808, 1814 by winding the sleeve 1816 upon the second, outer ring.As the sleeve 1816 is shortened, it supplies a retracting or openingforce away from the axis of the assembled wound retractor 1800. Thesecond, outer ring 1814 is easily turned upon itself or inverted by theuse of one or two hands 1818 of a single user 1820 and does not requirethe use of tools or assistants.

Referring to FIGS. 92-94, the inner ring 1808 of the wound retractor1800 may be circular, oval, elliptical or otherwise shaped to provideeasy insertion through the incision 1802 (FIG. 90) or opening in thebody wall 1804 (FIG. 90) and appropriate retraction once in place. Thecylindrical sleeve 1816 may be made from a thin film and include afirst, distal end that is coupled to the inner ring 1808. The sleeve1816 has a diameter and a length that forms an open central region 1822that is appropriate for the required retraction and thickness of thebody wall 1804 (FIG. 90). A second, proximal end of the sleeve 1816 iscoupled to the second, outer ring 1814 that is sized and configured toprovide a rigid, noncompliant, substantially circular structure. Therigid, noncompliant outer ring 1814 may include an extruded or moldedprofile that facilitates an inversion step for winding the sleeve 1816upon the outer ring.

The process of winding the sleeve 1816 upon the outer ring 1814 isillustrated in FIGS. 95-103. A user 1820 (FIG. 90) grasps the outer ring1814 and rolls it inwardly toward the center of the wound retractor1800. The user 1820 may roll the outer ring 1814 sequentially orasymmetrically using one hand 1818 at a time, or the user may use bothhands symmetrically. The outer ring 1814 may be rolled over and overseveral times, resulting in a shortening of the functional length of thesleeve 1816 coupled thereto. The outer ring 1814 is substantially rigidand noncompliant and, therefore, requires considerable force to invertor roll. An object of the invention is to minimize the force required toinvert the outer ring 1814 and increase the tension upon the sleeve1816. A very soft plastic or rubber material may be used to make a firstcircular tube 1830 and a second circular tube 1832 of a multiple-tubeouter cover portion 1824 of the outer ring 1814, such as a double-tubeouter ring or a triple-tube outer ring. The soft material favorstraction between the outer ring 1814 and the hands 1818 of the user1820. The rolling or inverting may, therefore, be accomplished with thethumbs 1826 and fingertips 1828 of the user 1820.

The first circular tube 1830 of the outer ring 1814 rotates through theopen central region 1822 of the second circular tube 1832 of the outerring, resulting in a first winding of the sleeve 1816. The secondcircular tube 1832 of the outer ring 1814 may then be rotated throughthe open central region 1822 of the first circular tube 1830 of theouter ring, resulting in a second winding of the sleeve 1816. Theseactions may be repeated until appropriate tension is placed upon thesleeve 1816 and sufficient retraction 1834 (FIG. 101) is applied to theincision 1802 (FIG. 90) in the body wall 1804. In one aspect, the hands1818 of the user 1820 alternately move the first circular tube 1830 ofthe outer ring 1814 through the central region 1822 of the secondcircular tube 1832 of the outer ring and so on in a first direction(FIG. 95) 1836, 1838, 1840 that results in a winding of the sleeve 1816outwardly and away from the axis of the wound retractor 1800.Alternatively, the hands 1818 of the user 1820 alternately move thefirst circular tube 1830 of the outer ring 1814 through the centralregion 1822 of the second circular tube 1832 of the outer ring and so onin a second direction (FIG. 96) that results in a winding of the sleeve1816 inwardly toward the axis of the wound retractor 1800. The innerring 1808 of the wound retractor 1800 is adapted for juxtaposition withthe inner surface 1812 of the body wall 1804 and the outer ring 1814 ofthe wound retractor is adapted for juxtaposition with the outer surfaceof the body wall. Both the inner ring 1808 and the outer ring 1814 areadapted for disposition relative to the incision 1802 in the body wall1804. The sleeve 1816 is adapted to traverse the incision 1802 in thebody wall 1804.

The construction of the rigid, noncompliant outer ring 1814 is furtherdetailed in FIGS. 95, 96 and 104-112 where a generally circularstructure is shown having a flexible, elastomeric plastic or rubberextrusion or molded elongate body 1824 having a first end 1842 and asecond end 1844. The outer ring 1815 of the wound retractor 1800 alsoincludes at least one lumen. In one aspect, the outer ring 1814 of thewound retractor 1800 includes a first lumen 1846 and a second lumen 1848extending from the first end 1842 to the second end 1844 through theelongate body 1824. This construction generally favors an extrusionmanufacturing method.

A rigid, noncompliant metal or plastic tubular hoop 1850 extends fromthe first end 1842 of the elongate body to the second end 1844 of theelongate body 1824. The rigid, noncompliant tubular hoop 1850 may bemade from a substantially straight tube and bent or formed into an opencircular form having a tube diameter slightly smaller than the lumendiameter of the elongate body 1824 when it is coupled end to end. Moreparticularly, a first circular rigid, noncompliant tubular hoop 1850 isinserted into the first lumen 1846 of the elongate body 1824. The firsttubular hoop 1850 includes a split that forms open ends 1858 of thefirst tubular hoop. A second circular rigid, noncompliant tubular hoop1852 is inserted into the second lumen 1848 of the elongate body 1824.The second tubular hoop 1852 includes a split that forms open ends 1860of the second tubular hoop.

A first core 1854 may be inserted into the lumen of the first circularrigid, noncompliant tubular hoop 1850 and a second core 1856 may beinserted into the lumen of the second circular rigid, noncomplianttubular hoop 1852. Each of the first and second cores 1854, 1856 mayinclude a first end and a second end to facilitate insertion into therespective lumens of the first and second tubular hoops 1850, 1852. Atleast one of the first and second cores 1854, 1856 may include asubstantially rigid, noncompliant wire or a stranded cable. The firstcore 1854 is advanced through the lumen of the first rigid, noncomplianttubular hoop 1850 so that the ends of the core are an appropriatedistance away from the open ends 1858 thereof (FIG. 96), such assubstantially opposite the open ends of the first tubular hoop. Thesecond core 1856 is similarly advanced through the lumen of the secondrigid, noncompliant tubular hoop 1852 so that the ends of the core arean appropriate distance away from the open ends 1860 thereof (FIG. 95),such as substantially opposite the open ends of the second tubular hoop.The ends of the first and second cores 1854, 1856 may be positionedabout 180° from the open ends of the rigid, noncompliant circularlyformed tubular hoops 1850, 1852.

The cores 1854, 1856 stabilize the open ends of the rigid, noncomplianttubular hoops 1850, 1852 within the lumens 1846, 1848 of the outer ring1814 so that the open ends of the rigid, noncompliant tubular hoopsremain substantially constantly aligned as they open and close inresponse to the rolling action 1836, 1838, 1840 applied to the outerring. Each of the combinations of the first tubular hoop 1850 with thefirst core 1854 and second tubular hoop 1852 with the second core 1856functions as an axle about which the outer ring 1814 may turn for half arotation, or 180°. More particularly, the first circular tube 1830 ofthe outer ring 1814 of the wound retractor 1800 may be rolled outsidethe second circular tube 1832 of the outer ring with the circumferenceof the first split tubular hoop 1850 in the first circular tubeexpanding to clear the second split tubular hoop 1852 in the secondcircular tube. Likewise, the second circular tube 1832 of the outer ring1814 of the wound retractor 1800 may be rolled outside the firstcircular tube 1830 of the outer ring with the circumference of thesecond split tubular hoop 1852 in the second circular tube expanding toclear the first split tubular hoop 1850 in the first circular tube.

Referring to FIGS. 112-116, an outer ring 1814 is shown including anextruded or molded profile 1824 having a first circular tube 1830 and asecond circular tube 1832. The outer ring 1814 may include a crosssection that resembles the numeral eight (8). The first circular tube1830 and the second circular tube 1832 are axially spaced from eachother and are coupled together through a substantially thin mid-section1862. The outer ring 1814 includes the first lumen 1846 in the firstcircular tube 1830 and the second lumen 1848 in the second circular tube1832. A first rigid, noncompliant tubular hoop 1850 having a split thatforms open ends 1858 may be inserted into the first lumen 1846 of theouter ring 1814 and a second rigid, noncompliant tubular hoop 1852having a split that forms open ends 1860 may be inserted into the secondlumen 1848 of the outer ring. A rigid, noncompliant core 1854, 1856,such as a wire hoop or a loop of stranded cable, is inserted into thelumen of each of the rigid, noncompliant tubular hoops 1850, 1852 andadvanced until the ends of the respective core are positioned wellwithin the rigid, noncompliant tubular hoops. The first and second cores1854, 1856 serve to maintain alignment of the two opposed ends of therigid, noncompliant tubular hoops 1850, 1852. The tubular hoops 1850,1852 containing cores 1854, 1856 are subsequently advanced to positionswell within the lumens 1846, 1848 of the outer ring 1814. Moreparticularly, the first tubular hoop 1850 is oriented such that the openends 1858 of the first tubular hoop are positioned away from the firstand second ends 1842, 1844 of the first circular tube 1830 of the outerring 1814, such as substantially opposite the first and second ends ofthe first circular tube. Similarly, the second tubular hoop 1852 isoriented such that the open ends 1860 of the second tubular hoop arepositioned away from the first and second ends 1888, 1892 of the secondcircular tube 1832 of the outer ring 1814, such as substantiallyopposite the first and second ends of the first circular tube.

Referring to FIG. 113, the outer ring 1814 may include a highlyresilient outer portion 1824, a first rigid, noncompliant compositetubular hoop 1850, a second rigid, noncompliant composite tubular hoop1852, a first core 1854, such as a rigid, noncompliant metallic memberand a second core 1856, such as a rigid, noncompliant metallic centralmember. The rigid, noncompliant tubular hoops 1850, 1852 are sized andconfigured to maintain a generally circular shape relative to thecentral axis of the wound retractor 1800 (FIG. 90). In addition, thecores 1854, 1856 within the tubular hoops 1850, 1852 provide additionalrigidity and also maintain alignment of the ends 1858, 1860 of thetubular hoops. The rigid, noncompliant composite tubular hoops 1850,1852 may be made from composites that are well known in the art, such asphenolic, polycarbonate, polyester or other plastics filled with glassfiber, carbon fiber or other well known materials.

Referring to FIG. 114, the outer ring 1814 may include a highlyresilient outer portion 1824, a first rigid, noncompliant metallictubular hoop 1850, a second rigid, noncompliant metallic tubular hoop1852, a first core 1854, such as a rigid, noncompliant metallic member,and a second core 1856, such as a rigid, noncompliant metallic member.The rigid, noncompliant tubular hoops 1850, 1852 are sized andconfigured to maintain a generally circular shape relative to thecentral axis of the wound retractor 1800 (FIG. 90). In addition, thecores 1854, 1856 within the rigid, noncompliant tubular hoops 1850, 1852provide additional rigidity and also maintain alignment of the ends1858, 1860 of the central tubular hoops.

Referring to FIG. 115, the outer ring 1814 may include a highlyresilient outer portion 1824, a first rigid, noncompliant metallictubular hoop 1850, a second rigid, noncompliant metallic tubular hoop1852, a first core 1854, such as a substantially rigid, noncompliantcomposite member and a second core 1856, such as a substantially rigid,noncompliant composite member. The rigid, noncompliant tubular hoops1850, 1852 are sized and configured to maintain a generally circularshape relative to the central axis of the wound retractor 1800 (FIG.90). In addition, the composite cores 1854, 1856 within the rigid,noncompliant tubular hoops 1850, 1852 provide additional rigidity andalso maintain alignment of the ends 1858, 1860 of the central tubularhoops. The rigid, noncompliant composite cores 1854, 1856 may be madefrom composites that are well known in the art, such as phenolic,polycarbonate, polyester or other plastics filled with glass fiber,carbon fiber or other well known materials.

Referring to FIG. 116, the outer ring 1814 may include a highlyresilient outer portion 1824 and solid hoops 1863 within the lumens1846, 1848 of the external retention member.

Referring to FIG. 117, the outer ring 1814 may include a highlyresilient extruded or molded outer portion 1864 having a first circulartube 1868, a second circular tube 1870 and a third circular tube 1872.The first circular tube 1868 is a large diameter cord. The secondcircular tube 1870 is a large diameter cord that is separated from thefirst circular tube 1868 by a third, smaller central circular tube 1872that has a lumen 1874 therethrough. Alternatively, the three cords orcircular tubes 1868, 1870, 1872 may all be substantially the same size.The first, second and third circular tubes 1868, 1870, 1872 aresubstantially coaxially aligned and each includes a substantiallyannular axis of substantially equal diameter. The first and secondcircular tubes or cords 1868, 1870 cooperate to provide a détente orsnap-over as the first and second cords are sequentially rolled over thethird circular tube 1872. The lumen 1874 of the central, third circulartube portion 1872 is supplied with a rigid, noncompliant hoop 1876 thatis constructed from a length of material that has been formed tosubstantially the diameter of the wound retractor 1800. The rigid,noncompliant hoop 1876 functions as an axle.

Referring to FIG. 118, the outer ring 1814 may include a moderatelyresilient extruded or molded outer portion 1864 having a first circulartube 1868, a second circular tube 1870 and a third circular tube 1872.The first circular tube 1868 is a large diameter cord having a lumen1878 therethrough. The second circular tube 1870 is a large diametercord having a lumen 1880 therethrough and is separated from the firstcircular tube 1868 by the third, smaller circular tube 1872 that has alumen 1874 therethrough. Alternatively, the three circular tubes cords1868, 1870, 1872 may all be substantially the same size. The first,second and third circular tubes 1868, 1870, 1872 are substantiallycoaxially aligned and each includes a substantially annular axis ofsubstantially equal diameter. The first and second circular tubes orcords 1868, 1870 cooperate to provide a détente or snap-over as thecords are sequentially rolled over the third circular tube 1872. Thelumen 1874 of the third circular tube 1872 is supplied with a rigid,noncompliant hoop 1876 that is constructed from a length of material,such as a metallic material, that has been formed to substantially thediameter of the circular retractor 1800. The rigid, noncompliant hoop1876 functions as an axle.

Referring to FIG. 119, the outer ring 1814 may include a highlyresilient extruded or molded outer portion 1864 having a first circulartube 1868, a second circular tube 1870 and a third circular tube 1872.The first circular tube 1868 is a large diameter cord having a lumen1878 therethrough. The second circular tube 1870 is a large diametercord having a lumen 1880 therethrough and is separated from the firstcircular tube 1868 by the third, smaller circular tube 1872 that has alumen 1874 therethrough. Alternatively, the three circular tubes orcords 1868, 1870, 1872 may all be substantially the same size. Thefirst, second and third circular tubes 1868, 1870, 1872 aresubstantially coaxially aligned and each includes a substantiallyannular axis of substantially equal diameter. The first and secondcircular tubes or cords 1868, 1870 cooperate to provide a détente orsnap-over as the cords are sequentially rolled over the third circulartube 1872. The lumen 1874 of the third circular tube 1872 is configuredto remain hollow and unfilled. The lumens 1878, 1880 of the first andsecond circular tubes are supplied with rigid metallic first and secondtubular hoops 1850, 1852 therein, respectively, that contain rigid,first and second cores 1854, 1856, such as noncompliant circular wires.The hollow third circular tube 1872 provides additional resilience thatallows the first and second circular tubes 1868, 1870 to pass througheach other.

Referring to FIG. 120, the outer ring 1814 may include a highlyresilient extruded or molded outer portion 1864 having a first circulartube 1868, a second circular tube 1870 and a third circular tube 1872.The first circular tube 1868 is a large diameter cord having a lumen1878 therethrough. The second circular tube 1870 is a large diametercord having a lumen 1880 therethrough and is separated from the firstcircular tube 1868 by a third, smaller circular tube 1872 that has nolumen therethrough. Alternatively, the three circular tubes or cords1868, 1870, 1872 may all be substantially the same size. The first,second and third circular tubes 1868, 1870, 1872 are substantiallycoaxially aligned and each includes a substantially annular axis ofsubstantially equal diameter. The first and second circular tubes orcords 1868, 1870 cooperate to provide a détente or snap-over as thecords are sequentially rolled over the third circular tube 1872. Thecord of the third circular tube 1872 is solid. The lumens 1878, 1880 ofthe first and second circular tubes 1850, 1852 are supplied with rigid,metallic first and second tubular hoops 1850, 1852, respectively,therein that contain cores 1854, 1856, such as rigid, noncompliantcircular wires. The solid third circular tube 1872 provides a resilientaxle that allows the first circular tube 1868 and the second circulartube 1870 to pass through each other.

Referring to FIGS. 121-123, the wound retractor 1800 may include afirst, inner ring 1808, a second, outer ring 1814, and a sleeve 1816coupling the inner ring to the outer ring. The inner ring 1808 may besized and configured to be deformed and placed through the incision 1802in the body wall 1804 and subsequently into the body cavity 1810. Thesleeve 1816 extends through the incision 1802 in the body wall 1804 andis coupled to the second, outer ring 1814 that is sized and configuredto be inverted upon itself or rolled to wind the sleeve 1816 upon thesecond, outer ring. The outer ring 1814 may include a helical rigid,noncompliant element having a shape similar to a Mobius strip. Thehelical outer ring 1814 may be formed by twisting an extruded or moldedelement, such as a dual-lumen element 1882, so that the first end 1884of the first lumen 1886 communicates with the second end 1888 of thesecond lumen 1890 and the first end 1892 of the second lumen 1890communicates with the second end 1894 of the first lumen 1886.

The ends 1884, 1888, 1892, 1894 of the extruded or molded form 1814 arenot joined together. A first split tubular hoop 1850 is inserted intothe first end 1884 of the first lumen 1886 and advanced until it exitsthe second end 1894 of the first lumen where it is then inserted intothe first end 1892 of the second lumen 1890. A first core 1854, such asa rigid, noncompliant wire or a cable may then be inserted into thefirst tubular hoop 1850 and advanced until the ends of the first coreare well within the solid portion of the first tubular hoop, such assubstantially opposite the ends 1884, 1886 of the first tubular hoop.The ends of the first core 1854 may be separated from the ends of thefirst rigid, noncompliant tubular hoop 1850 by about 180°. The firsttubular hoop 1850 and first core 1854 are then advanced within the firstlumen 1886 of the extruded or molded element to a point distant from thefirst and second ends 1884, 1888 of the twisted circular form 1814. Asecond rigid, noncompliant tubular hoop 1852 and a second core 1856 areinserted into the first end 1892 of the second lumen 1890 of theextruded or molded element and advanced as described above. Theassembly, which forms an outer ring 1814 in the form of a twistedexternal rigid, noncompliant outer ring, may be inverted or rolled towind the sleeve 1816 upon the outer ring. The helical orientation of therigid, noncompliant outer ring 1814 avoids an extreme détente orsnap-over associated with two discrete rigid, noncompliant portions thatmust pass through each other in a rolling or inverting motion to windthe sleeve 1816 upon the rigid, noncompliant outer ring.

An advantage associated with the modified surgical access device is itenables a surgeon to quickly retract and protectively line an abdominalwall incision while being able to easily accommodate variations inabdominal wall thickness between patients. In addition, the deviceeffectively seals around the interior and exterior of the incision, andallows a sealing cap to be coupled to seal the abdominal cavity and toenable a laparoscopic procedure to be performed.

Many alterations and modifications may be made by those having ordinaryskill in the art without departing from the spirit and scope of theinvention. For these reasons, the above description should not beconstrued as limiting the invention, but should be interpreted as merelyexemplary of the embodiments.

1. A wound retractor adapted to retract a surgical incision in abiological body wall to a desired diameter, comprising: a double-tubeouter ring having an annular axis, the double-tube outer ring includinga first circular tube and a second circular tube that are separatedaxially, each of the circular tubes including a lumen, the outer ringbeing adapted for juxtaposition with an outer surface of the body walland for disposition relative to the incision in the body wall; an innerring, the inner ring being adapted for juxtaposition with an innersurface of the body wall and for disposition relative to the incision inthe body wall; a distensible sleeve coupling the outer ring to the innerring, the sleeve being adapted to traverse the incision in the bodywall; a first substantially noncompliant, split hoop positioned in thelumen of the first circular tube; and a second substantiallynoncompliant, split hoop positioned in the lumen of the second circulartube, wherein, the outer ring being adapted to roll over itself andaround the annular axis to roll the sleeve around the outer ring.
 2. Thewound retractor of claim 1, each of the first and second split hoopsfunctioning as an axle about which the outer ring may turn for half arotation.
 3. The wound retractor of claim 1, the sleeve including amaterial that is flexible and impermeable to fluids and bacteria.
 4. Thewound retractor of claim 1, the inner ring being made of materialshaving sufficient hardness to retain the shape of the inner ring afterinsertion of the inner ring into a body cavity.
 5. The wound retractorof claim 1, the outer ring being made of materials that allow the outerring to be turned around its annular axis.
 6. The wound retractor ofclaim 1, the first circular tube of the outer ring being coupled to thesecond circular tube of the outer ring by a web.
 7. The wound retractorof claim 1, at least one of the first and second noncompliant, splithoops including a single split about its circumference, the splitcreating a first end of the split hoop and a second end of the splithoop, the first and second ends of the split hoop substantially abuttingeach other when the split hoop is in its neutral position.
 8. The woundretractor of claim 1, at least one of the first and second noncompliant,split hoops including a single split about its circumference with thesplit creating a first end of the split hoop and a second end of thesplit hoop, the split hoop including a space between the first andsecond ends when the split hoop is in its neutral position.
 9. The woundretractor of claim 8, the space between the first and second ends of thesplit hoop being sufficient to substantially prevent the first andsecond ends of the split hoop from contacting each other when the splithoop contracts while rolling the sleeve around the outer ring.
 10. Thewound retractor of claim 1, at least one of the first and secondnoncompliant, split hoops including two or more splits about thecircumference of the split hoop, the splits creating a plurality of hoopportions, each hoop portion including a first end and a second end, thetwo or more splits being substantially equally spaced about thecircumference of the split hoop, the first and second ends of adjacenthoop portions substantially abutting each other when the split hoop isin its neutral position.
 11. The wound retractor of claim 1, at leastone of the first and second noncompliant, split hoops including two ormore splits about the circumference of the split hoop, the splitscreating a plurality of hoop portions, each hoop portion including afirst end and a second end, the two or more splits being substantiallyequally spaced about the circumference of the split hoop, the split hoopincluding a space between the first and second ends of adjacent hoopportions when the split hoop is in its neutral position.
 12. The woundretractor of claim 11, the sum of the spaces between the first andsecond ends of adjacent hoop portions being sufficient to substantiallyprevent the first and second ends of adjacent hoop portions fromcontacting each other when the split hoop contracts while rolling thesleeve around the outer ring.
 13. A wound retractor adapted to retract asurgical incision in a biological body wall to a desired diameter,comprising: a double-tube outer ring having an annular axis, thedouble-tube outer ring including a first circular tube and a secondcircular tube that are separated axially, each of the circular tubesincluding a lumen, the outer ring being adapted for juxtaposition withan outer surface of the body wall and for disposition relative to theincision in the body wall, the outer ring being made of materials thatallow the outer ring to be turned around its annular axis; an innerring, the inner ring being adapted for juxtaposition with an innersurface of the body wall and for disposition relative to the incision inthe body wall, the inner ring being made of materials having sufficienthardness to retain the shape of the inner ring after insertion of theinner ring into a body cavity; a distensible sleeve coupling the outerring to the inner ring, the sleeve being adapted to traverse theincision in the body wall, the sleeve including a material that isflexible and impermeable to fluids and bacteria; a first substantiallynoncompliant, split hoop positioned in the lumen of the first circulartube; and a second substantially noncompliant, split hoop positioned inthe lumen of the second circular tube, wherein, the outer ring beingadapted to roll over itself and around the annular axis to roll thesleeve around the outer ring, each of the first and second split hoopsfunctioning as an axle about which the outer ring may turn for half arotation.
 14. The wound retractor of claim 13, at least one of the firstand second noncompliant, split hoops including a single split about itscircumference, the split creating a first end of the split hoop and asecond end of the split hoop, the first and second ends of the splithoop substantially abutting each other when the split hoop is in itsneutral position.
 15. The wound retractor of claim 13, at least one ofthe first and second noncompliant, split hoops including a single splitabout its circumference with the split creating a first end of the splithoop and a second end of the split hoop, the split hoop including aspace between the first and second ends when the split hoop is in itsneutral position.
 16. The wound retractor of claim 15, the space betweenthe first and second ends of the split hoop being sufficient tosubstantially prevent the first and second ends of the split hoop fromcontacting each other when the split hoop contracts while rolling thesleeve around the outer ring.
 17. The wound retractor of claim 13, atleast one of the first and second noncompliant, split hoops includingtwo or more splits about the circumference of the split hoop, the splitscreating a plurality of hoop portions, each hoop portion including afirst end and a second end, the two or more splits being substantiallyequally spaced about the circumference of the split hoop, the first andsecond ends of adjacent hoop portions substantially abutting each otherwhen the split hoop is in its neutral position.
 18. The wound retractorof claim 13, at least one of the first and second noncompliant, splithoops including two or more splits about the circumference of the splithoop, the splits creating a plurality of hoop portions, each hoopportion including a first end and a second end, the two or more splitsbeing substantially equally spaced about the circumference of the splithoop, the split hoop including a space between the first and second endsof adjacent hoop portions when the split hoop is in its neutralposition.
 19. The wound retractor of claim 18, the sum of the spacesbetween the first and second ends of adjacent hoop portions beingsufficient to substantially prevent the first and second ends ofadjacent hoop portions from contacting each other when the split hoopcontracts while rolling the sleeve around the outer ring.